Green Salary in Danvers, MA

Liaison with suppliers: Communicate and address supplier quality issues, customer complaints, CAPA, and improvement opportunities.Managed APCD Global ASL: Oversee the onboarding process, scorecard management, and act as Subject Matter Expert (SME) for supplier processes during internal and external audits.Flexibility: Available to work nonstandard hours or alternate shifts to support operations in North America and Asia.Minitab: Proficient in using Minitab for statistical analysis and process improvement.SPC (Statistical Process Control): Implement and maintain SPC methods to monitor and control manufacturing processes.APQP (Advanced Product Quality Planning): Familiarity with APQP methodologies for new product development and introduction.Supplier Performance Reporting: Generate and present monthly reports on supplier performance.Collaboration: Work closely with Quality Engineering (QE) and First Article Inspection (FAI) teams on FAI processes, and conduct supplier surveys and audits.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The ideal candidate has their Bachelor's Degree in Engineering or a Science discipline or equivalent. Additionally, 2+ years of experience in Quality, Manufacturing and/or Engineering is preferred.Supplier Management: Ability to effectively manage relationships with suppliers, including communication, negotiation, and issue resolution.Process Improvement: Proficiency in identifying inefficiencies in processes and implementing solutions to enhance efficiency and effectiveness.Product Quality: Strong understanding of quality control processes and methodologies to ensure products meet or exceed quality standards.Six Sigma: Familiarity with Six Sigma methodologies and tools for process improvement and defect reduction, such as DMAIC (Define, Measure, Analyze, Improve, Control) and statistical analysis techniques.

You will be in responsible for developing and executing equipment and process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, and other key internal/external stakeholders ( R&D, Supply Chain, etc.). Experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet MilliporeSigma, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site and divisional quality goals and priorities. Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site. Primary Responsibilities: Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. Driving cost reduction projects and reviewing/analyzing/improving the effectiveness of quality improvement tools and programsLeads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Application Validation Plans.Leads the execution of Risk Management deliverables to ensure compliance to ISO 9001 and demonstrates a primary commitment to patient safety.Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, customer complaint investigations, and CAPA's.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls for product validation, process validation, and applicable validation activities.Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers. Coach and mentor new and junior members of the team.Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validationProactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance eventsLead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.Executing/supporting material qualification projects and leading/assisting with investigations related to raw materials/components.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls (CTQ, CQA, CPP) for product validation, process validation, and applicable validation activities.Review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes.Generate CTQ monitoring data for equipment and processes.Performing root cause analysis and corrective actions for process and equipment-related quality issuesProvides project direction, coaching, and mentoring for engineering and technical team personnel.Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.Supports internal and external regulatory audits.Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.Support development, implementation, and training of site quality initiatives. Who you are:Basic Qualifications7+ years validation experience handling of multiple projects within the biopharma, biotech or medical device industries.Minimum B.S. degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalentFull understanding of product, equipment and process validationDemonstrated capability of applying risk management concepts and toolsHands-on experience in troubleshooting and the application of quality system standardsExperienced at working in cross-functional teamsStrong written and verbal communication skills (internal/external)Strong teamwork and collaboration skillsExperience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processesExperienced with Quality & GxP IT compliance requirements Preferred Qualifications:ASQ Quality Engineer Certification (CQE)Six Sigma CertificationQuality by DesignApplied/industrial statistics experienceDetailed Knowledge of GMP, ISO and FDA design and development quality requirementsKnowledge of aseptic processing

An Engineering Technician 2 is responsible in ensuring that production equipment is running efficiently and effectively. Collaborate with team members while following strict engineering standards. Additionally, assist the engineering team in maintaining crucial systems and components. Hours for this role Friday through Sunday from 6am-6pm Who You Are:Minimum Qualifications: Associate Degree in Industrial Engineering, Mechanical Engineering or other engineering discipline ORHigh School Diploma or GED3+ years of experience in industrial or mechanical equipment maintenance. Preferred Qualifications: Bachelor's Degree in Mechanical or Electrical Engineering 5+ years of experience in industrial or mechanical equipment maintenance Strong understanding of Good Manufacturing PracticesDemonstrated leadership in project settingExcellent analytical and problem-solving abilitiesAbility to multitask and set priorities RSREMD

EHS Specialists are responsible for planning, implementing, and enforcing an organization's Environmental, Health, and Safety (EHS) policies and procedures. The primary objective is to create a workplace that is safe and healthy for people and the environment. The EHS Specialist take ownership of workplace safety programs and may train staff on proper procedures to avoid accidents or injuries. They assist the Site EHS Head and EHS Engineer in solving issues, investigating incidents, and in developing overall strategies. Specific responsibilities include: Collaborates with the operations group and EHS team to identify and implement ways to minimize workplace hazardsCreates and implements programs that will assist employees to avoid repetitive stress, cumulative trauma, and other injuries and impairmentsSupport in incident investigation and development of corrective actions including ensuring completion of the corrective actionMaintain records, inputting data into Corporate DatabaseAssist in EHS related projectsCollaborates with supervisors and managers to offer practical suggestions to enhance the safety and productivity of work environmentsDevelops and maintains related records and reports of observations, recommendations, and implementation proceduresAssist EHS Team with the completion of internal and external audits or assessments and help coordinate actions to meet objectives as set out in ISO14001, health and safety, and business continuity management systemsRaise EHS awareness and build EHS competencies by defining, setting up and delivering training, and developing and/or reviewing work and safety instructionsPerforms other related duties as assigned Physical Attributes: Lift up to 50 pounds Who You Are:Minimum Qualifications:Bachelor's Degree in Environmental Health and Safety, Biology, or Environmental Engineering1+ years of work experience in EHS or risk management 3+ years of experience in manufacturing environment Preferred Qualifications: Proficient in Microsoft Office Suite Excellent interpersonal skills Resourceful and creative problem-solving skillsThorough understanding of human behavior and musculoskeletal functionsExcellent organizational skills and attention to detailAbility to conduct and correctly analyze risk assessments and evaluationsIn-depth understanding of safe workplace practices and environmentally friendly strategiesFamiliarity with OSHA and EPA regulations and other applicable laws and guidelines