Quality Engineer Salary in California, USA

Quality Engineer IIIJob LocationsUS-CA-Redwood CityReq No.2020-6485CategoryITTypeRegular Full-TimeSummary of Major ResponsibilitiesAs a member of the Quality Engineering (QE) team in the IT Software Engineering department, the QE will play a key role in contributing to the successful delivery of products from conception to go-live with emphasis on software quality for an exceptional customer experience. This role will be involved in all phases of system development, including requirements, analysis, design, development, testing, and support.  The ideal candidate must demonstrate the ability to understand system architecture, design, implementation and possess the ability to succinctly develop the strategy to deliver high-quality results in a time-sensitive environment. Essential Duties and ResponsibilitiesParticipate in requirements, design, and review meetings.Execute test strategy, test plan, and risk assessment leading to successful implementation and timely project completion.Create, maintain, and execute test cases/test scripts (manual/automated) for the user stories developed to build new features and product functionality.Develop test scripts to verify workflow functionality and REST API’s.Create and execute SQL queries to verify data integrity.Report, track, and escalate anomalies discovered during testing and ensure closure on the issues.Collaborate with cross-functional teams to ensure timely and effective testing, as part of a regular release schedule.Ability to work proactively, independently, or as part of a team on multiple tasks and projects, and quickly learn new technologies.Strong organizational, problem-solving, and analytical skills.Excellent written and verbal communication; inclusive of technical documentation skills.Ability to integrate and apply feedback in a professional manner.Ability to prioritize and drive to results with a high emphasis on quality.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability and means to travel between Redwood City locations.Ability to travel 5% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor’s Degree in Computer Science or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree.5+ years of experience with web-based enterprise application testing and technical/domain expertise in CRM solutions.2+ years of experience using tools like SOAPUI, JMeter, Selenium, TestNG.2+ years of experience working in an Agile/Scrum-like environment.Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred QualificationsExperience testing web services and/or REST API using JSON/XML.Working knowledge of CI/CD framework.Knowledge of SDLC processes.Experience in SaaS, SaMD, or Cloud environments.Experience in SOA environments. Experience in working in a regulated environment (e.g., SOX, HIPAA, CLIA, GCP, and/or FDA). #LI-SS1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

RBC Bearings Incorporated (NYSE: RBC/RBCP) is a leading international manufacturer of highly engineered precision bearings, components, and essential systems for the industrial, defense, and aerospace industries. Founded in 1919, the Company is primarily focused on producing highly technical and/or regulated bearing products and components requiring sophisticated design, testing, and manufacturing capabilities for the diversified industrial, aerospace, and defense markets. We currently have 56 facilities, of which 37 are manufacturing facilities in ten countries and our market capitalization is approximately $6.2 billion.Essential Functions of the Job:Work within the company policies to manage the quality assurance aspects of new product introduction.Provide oversight of the manufacture of products to ensure that engineering documentation is consistent with manufacturing methods employed.Coordinate activities associated with “first article build” of new products, ensuring that fabricated items are traceable to documented standards at the time of release of product into the production mode.Develop test methods/procedures to support product validation efforts.Maintain test equipment to traceable standards accepted in the aerospace industry.Perform performance validation tests to meet customer specifications.Generate test reports of performance validation tests.QE support of Prime Customers for first articles and corrective action.Reviewing contracts, specifications, purchase orders, and planning.Planning and implementing quality initiatives throughout the organization.Recommending, reviewing & approving changes to manufacturing plans & drawings based on customer requirements.Performing internal & external audits.Participating in RCCA investigations as required.Assisting with training of the RBC Divisions in regards to Customer and Quality System.The preceding functions have been provided as examples of the types of work performed by employees assigned to this job function. Management reserves the right to add, modify, change or rescind the work assignments of different positions and to make reasonable accommodations so that qualified employees can perform the essential functions of the job.Education:Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, or any other related fieldExperience:5-10 years in aerospace qualityKnowledge/ Skills/ Abilities:Practical experience in precision inspection equipment and calibrationFamiliarity with aerospace shops and materialsFamiliarity with Dimensional Inspection and GD&TFamiliarity with AS9100 systems, internal audits, customer audits, NADCAP processesOrganizational and leadership skillsEffective time managementAnalytical thinkerDetail orientedExcellent written and oral communication skills.Working knowledge of Microsoft office productsAbility to work both independently and as part of a teamAbility to multitask in a fast-paced environmentMust enjoy the challenges of working in the fast pace, sometimes demanding Aerospace World.Physical & Environmental Factors:While performing the duties of this job, the employee generally works indoors within the office and manufacturing areas.The employee is occasionally exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals.The noise level in the work environment is usually moderate or loud.The employee is regularly required to sit, talk, and listen.The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms.The employee is occasionally required to stand and walk.The employee must occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this job include close vision.This role is subject to compliance with the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR), which requires the incumbent to be either a US citizen, lawful permanent resident [“green card” holders] or have refugee or asylee status.**Please note that the salary range information is only applicable for California. The pay range represents the low and high end of the salary range we reasonably expect to pay for this position at the time of posting. An employee’s pay position within the salary range will be based on several factors, including, but not limited to, geographic location, experience, education, skills, qualifications, performance, and business or organizational needs. Pay Range: $75,000 to $85,000 annually.RBC Bearings is an Equal Opportunity Employer to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of Position:As Intuitive's da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process. Intuitive seeks a proven technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, drive projects to implement these initiatives, and serve as a professional consultant to help solve the most technically challenging quality problems. The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization. You will not abide "process red tape", instead passionately seek the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods. Position Details: The position is a Quality Engineer to be in Sunnyvale, California and will interface and support manufacturing operations.Position Details:The position is for a Quality Engineer in Sunnyvale, California and will interface and support new product development and manufacturing operations for Single Port business unit.Roles & Responsibilities:Initial Roles and responsibilities for this position has responsibility will include the following: 50% in new product development, 20% involvement in supporting manufacturing operations, 10% failure investigation, 10% preforming complex inspection and 10% quality advocacy and project management.Develop and apply corporate level quality metrics.Drive and project manage quality initiatives in one or more of these focus areas: Product Quality, Process Quality, Production facility validation planning, execution, and documentation.Product Development-Handle projects of various product and subsystem types (Instruments and Accessories for SP System - new products, product improvements, etc.)Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Sunnyvale, ISI Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge.Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.Develop and implement methods and procedures for disposition of discrepant material.Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.Failure Analysis- Provide quality expertise post market release to the quality engineering support team to analyze the returned product.Perform deep technical failure analysis based on the physics of failure.Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.Requirements:Minimum Education: bachelor's degree in electrical, mechanical or system engineering, math, or physics, advanced degree preferred.Minimum 4+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 2 years in medical device design or manufacturing environmentUnderstands Quality and compliance System.Understands of CFR 21 820/ ISO 13485 requirements for making process or design changesHave good grasp of quality control and tools.Able to learn the product and process quickly and assesses defects' impact to product.Understands root cause investigation process and able to initiate routine problem-solving investigations.Involved in Design and process improvement projects in the pastAble to review Qualification and Validation protocols.Understands manufacturing metrics.Understands basic Excel data analysis operations (e.g., Pareto, charts, and trends)Able to work in various project teams as the Quality SMEAble to communicate work tasks to various project team members.Capable of Compiling data in format appropriate for presentationPersonality Requirements:Able to cope with changes and uncertainties; and handle associate risks comfortably.Able to ask meaningful questions and solve issues in a least burdensome approach.Motivated by results.Listens and respects others.Demonstrates constructive work relationship with others in the organization.Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues.Sets personal goals aligning with the team goal. Qualifications Requirements:Minimum Education: bachelor's degree in electrical, mechanical or system engineering, math, or physics, advanced degree preferred.Minimum 5+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 2 years in medical device design or medical device manufacturing environmentExperienced in New Product Introduction (NPI) and/or New Product Development (NPD).Understands Quality and compliance System.Understands of CFR 21 820/ ISO 13485 requirements for making process or design changesHave good grasp of quality control and tools.Able to learn the product and process quickly and assesses defects' impact to product.Understands root cause investigation process and able to initiate routine problem-solving investigations.Involved in Design and process improvement projects in the pastAble to review Qualification and Validation protocols.Understands manufacturing metrics.Understands basic Excel data analysis operations (e.g., Pareto, charts, and trends)Able to work in various project teams as the Quality SMEAble to communicate work tasks to various project team members.Capable of Compiling data in format appropriate for presentationPersonality Requirements:Able to cope with changes and uncertainties; and handle associate risks comfortably.Able to ask meaningful questions and solve issues in a least burdensome approach.Motivated by results.Listens and respects others.Demonstrates constructive work relationship with others in the organization.Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues.Sets personal goals aligning with the team goal. Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Base Salary Range Region 1: $100,500 USD - $144,700 USD Base Salary Range Region 2: $85,400 USD - $123,000 USD Shift: Day Travel: 10% of the time Workplace Type: Onsite - This job is fully onsite.

Quality EngineerBCforward is currently seeking a highly motivated Quality Engineer for an opportunity in Los Angeles, CA 91605 Position Title: Quality EngineerLocation: Los Angeles, CA 91605 Anticipated Start Date: ASAPPlease note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date. Expected Duration: 6 Months Contract Job Type: Mon - Friday 40.00 Hours Per Week, Onsite Pay Range: [$33.00- [$44.00]Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.). Job Description: *** Needs to have strong AS9100D experience**Job DesignationQuality Systems Engineer 2 role provides a range of expertise to ensure that the products are free of flaws and function as designed. The QSE will participate in assuring high reliability and proper performance per product requirements.Job Core ResponsibilitiesOversees effective implementation of Quality Management System throughout the company, including any business (quality) accreditations.Organize and manage the site Internal Audit ProgramLead cross-functional team of auditor as "Lead Auditor."Host external audits.Analyzes audit results and determines proper corrective and preventative (risk) action.Analyze current and future procedural needs of the business.Maintains site procedural content and coordinates the issuing of these documents.Support and implement other functional areas where applicable of Group Business Management Systems "GBMS" requirement for the site.Consistent exercise of independent judgement and discretion in matters of significanceCollaborate quality data for monitoring targets.Report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.Support other functional areas with Quality Compliance needs.Manage site Qpulse "Electronic Quality Management System" and assist other functional area as required.Other responsibilities as assigned.Consistent exercise of independent judgment and discretion in matters of significanceRegular, consistent and punctual attendance is required. May need to work nights and weekends, variable schedule(s) and additional hours as necessary.Job SpecificationsEducation: Post-secondary degree in Engineering or equivalent combination of relevant education and work experience that will allow successful performance of job expectationsYears Experience: min 3 years of relevant experienceSkills:Knowledge of complex Quality Engineering processes and regulatory requirementsExcellent ability to apply a systematic and analytical approach to problem-solving.Advanced knowledge and ability to apply core concepts of engineering.Ability to interpret internal/external business challenges and make recommendations for improvements to products, processes or services.Ability to explain a range of complex technical information.Demonstrated analytical skills to proactively identify and solve problems.Effective interpersonal, verbal, and written communication skills to drive tasks to completion.Benefits:BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.Keywords:[KEYWORDS FOR SEO OPTIMIZATION]About BCforward:Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.Interested candidates please send resume in Word format Please reference job code 215607 when responding to this ad.Get job alerts by email.Sign up now!Join Our Talent Network!Job SnapshotEmployee TypeContractorLocationLos Angeles, CA (Onsite)Job TypeInformation TechnologyExperienceNot SpecifiedDate Posted05/14/2024

Quality Engineer - Aerospace North Hollywood, CASummaryThe Quality Systems Engineer role provides a range of expertise to ensure that the products are free of flaws and function as designed. Participates in assuring high reliability and oversees the quality standards of specific client product lines.ResponsibilitiesOversees effective implementation of Quality Management System throughout the company, including any business (quality) accreditationsOrganize and manage the site Internal Audit ProgramLead cross-functional team of auditor as "Lead Auditor"Host external audits- Analyzes audit results and determines proper corrective and preventative (risk) actionAnalyze current and future procedural needs of the businessMaintains site procedural content and coordinate the issuing of these documentsSupport and implement other functional areas where applicable of Group Business Management Systems "GBMS" requirement for the siteCollate quality data for monitoring targetsReport on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or systemSupport other functional areas with Quality Compliance needsManage site Qpulse "Electronic Quality Management System" and assist other functional area as requiredQualificationsEducation: Post-secondary degree in Engineering or equivalent combination of relevant education and work experienceMinimum 3 years of Quality Engineering experienceKnowledge of complex Quality Engineering processes and regulatory requirementsCAPA and NCR experienceAbility to oversee and develop inspection requirementsRun internal auditsAerospace and mechanical engineering aptitude highly desiredZero Defects Program experience a huge plus

Position: Quality Engineer I/IILocation: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description:This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require a presence on campus.This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures for device investigation and risk assessments of reported complaints from the field.Education and Experience:Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years of experience related to work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required.Proficient with the Microsoft Office suiteExperience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)Functional, physical, and visual testing of medical device equipment in a laboratory settingExperience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.Additional Skills:Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.Basic understanding of statistical techniquesPrevious experience working with lab/industrial equipment requiredSolid understanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical, and critical thinking skillsSolid understanding of processes and equipment used in assigned workKnowledge of and adherence to Quality systemsStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including the ability to manage project stakeholdersAbility to build productive internal/external working relationshipsRoles and Responsibilities:Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) - CAPAs, SCARs, as determined by the investigation.Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Quality EngineerFull-time / Permanent Salaried$73K - $120KAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do - and have a lot of fun doing it.About this Opportunity:The Quality Engineer will provide support for product/process quality activities within Vantedge Medical. Areas of assignment may include: Product/Process improvement efforts, equipment validations, supplier quality performance and quality systems support.Responsibilities:Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.Work with suppliers and Supply Chain department to improve overall performance.Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.).Assist the Director of Quality in maintaining ISO 13485 QMS.Create/Update work instructions and procedures as needed.Lead and/or create equipment validation protocols and reports.Undertake additional responsibilities or activities as required by Director of Quality.Requirements / Skills:4-year degree in Quality/Mechanical/Industrial engineering or a closely related field.2 years of work experience in a related field in a medical device or manufacturing environment.Understand in depth quality systems, ISO 13485 and/or 9001 standards.Ability to create, review, and revise operating procedures, work instructions in English.Specific training and demonstrated success in applying quality problem solving method, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.Minitab, JMP or other statistical software capabilities.*We are not accepting candidates from third party agencies.

At Blue Robotics, we enable the field of marine robotics with affordable components and systems. What does this really mean? We design cool tech for use underwater that enables tons of people and organizations to pursue their audacious dreams of exploring and learning about our oceans and waterways.As we grow and our users tackle more and more challenging subsea missions, the demands on our products grow. We've grown to be very good at manufacturing with a great team of engineers and technicians. The next step is to grow our team to include a Quality Engineer who is driven to make things even better, solving tough problems and enjoying the journey.We're headquartered in Torrance, California, where we have a smart and ambitious team running our supply chain, manufacturing, and inventory management while collaborating with our remote design and sales teams to bring new products to life. We have an appetite for constant improvement and work together to build great products and a great company.For this role, we're looking for someone who will care deeply about quality across our design, manufacturing, and operations elements, keep our customer's needs in mind, and be unafraid to speak up when there's room for improvement. We're searching for a person who is keen to start from near-scratch and build a great system, who loves to stay organized and documented along the way, and is willing to step into a running operation and get up to speed quickly.While you'll spend most of your time near the production, there will also be chances to use our products in the real world to fully understand what's important for our customers' success.Will it all be whipped cream and roses? Probably not. But as a team we'll chip away at this awesome, fun, and sometimes infuriating dream that we've decided deserves to become a reality.Key Responsibilities:Improve and develop new quality control processes and procedures for product manufacturing, assembly, and testing.Collaborate with design engineering, manufacturing engineering, operations, and production teams to ensure that quality requirements are met from product conception to delivery.Manage our quality inspection team and make sure they have the right systems and tools for the job.Perform inspections and audits of processes, materials, and finished products to identify non-conformities and areas for improvement.Establish and maintain quality metrics and performance indicators to track and report on product quality and process efficiency.Investigate root causes of quality issues and implement corrective and preventive actions to address them.Conduct supplier quality assessments and work closely with vendors to ensure the quality of incoming materials and components.Provide training and guidance to the production team on quality standards, procedures, and best practices.Participate in design reviews and risk assessments to ensure that product designs meet quality and reliability requirements.Support customer inquiries and feedback related to product quality and reliability.Qualifications:Bachelor's degree in engineering or a related field.Proven experience in quality engineering or a similar role, preferably in the manufacturing or robotics industry.Familiarity and experience with metrology tools and gauges.Strong knowledge of quality management principles, tools, and methodologies.Excellent problem-solving skills, with the ability to identify and resolve complex quality issues.Fantastic communication skills and the ability to interact with cross-functional teams and hold people accountable for their work.Detail-oriented and self-motivated, with a passion for delivering high-quality products and improving processes.Benefits:Medical, dental, & vision insuranceBasic life and AD&DVoluntary life insurance401(k) with 4% employer match20 PTO days + 10 HolidaysEducational Reimbursement Program ($1,000/year)How to Apply:Click through to complete a brief application and submit your resume as a PDF.

Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description:Education and Experience:Bachelor's degree in engineering, 0 - 4 years of experience related work experience requiredProficient with the Microsoft Office suiteExperience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)Functional, physical, and visual testing of medical device equipment in a laboratory settingExperience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.Roles and Responsibilities:Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) - CAPAs, SCARs, as determined by the investigation.Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Title: Engineer-2 (Quality)Location: Irvine, CADuration: Contract About the Client:Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless innovation, our partner stands at the forefront of revolutionizing healthcare. Key offerings include transcatheter heart valves, innovative transcatheter mitral solutions, advanced critical care monitoring systems, and state-of-the-art surgical valve technologies.Overview:The main function of the Quality Engineer is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities and develop/approve software documents.Job Responsibilities:• Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.• Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.• Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.• Perform dry-runs and execution of Software Validation Protocols.• Train, coach, and guide other employees on software documentation.• Other Incidental duties as required.Required Skills:• Proven expertise in usage of MS Office Suite;• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.• Working knowledge and understanding of statistical techniques.• Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.• Substantial knowledge of business acumen products and software technologies• Strong problem-solving, organizational, analytical and critical thinking skills• Substantial understanding of processes and equipment used in assigned work• Good leadership skills and ability to influence change• Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).• Strict attention to detail• Ability to interact professionally with all organizational levels• Ability to manage competing priorities in a fast paced environment• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlLevel of Independence:• Works independently without close supervision.• Compares and evaluates possible courses of action after considering various possibilities.• Applies knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.• Considers the cause and effect of activities.• Determines or effectively recommends course of action after considering potential risks of alternatives.• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive.Education/Experience:• Bachelor's degree in engineering required.• 2-4 years experience required.• Previous experience with software verification and validation activities in a medical device industry.