Quality Engineering Supervisor
Millipore Corporation

Job Info

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We are seeking a motivated Quality Engineering Supervisor to support device manufacturing at the Jaffrey Manufacturing site. This position will manage a small team of Quality Engineers and Quality Technicians and oversee three rapidly growing manufacturing work centers, partnering with Operations, Engineering, Product Management (Marketing) and EHS. The Supervisor will provide guidance and mentorship to his/her expanding team of quality engineers and quality technicians. In addition to the supervisory requirements, the candidate will also be responsible for providing day-to-day Quality Engineering support for a fast-paced device manufacturing operation, including: Evaluation of out-of-specification conditions and providing guidance for the disposition of non-conforming product and raw materialsLeading quality investigations (RCA and CAPA management)Perform statistical analysis and trending to assess and monitor product/process performanceWorking with cross functional teams to set the requirements to support product and process modifications; ensuring that Change Control requirements are met based on internal company procedures and applicable industry standards and regulationsLead and participate in the creation of risk assessments (product and process- FMEA)Participate in product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, data analysis, and write validation protocols and reportsCreate and revise Standard Operating Procedures, Test Methods, and other documentsA Shift: Monday - Friday 8AM - 5PM

Who You Are:

Minimum Qualifications:

Bachelors of Science Degree in a Scientific or Engineering discipline2+ years of Quality Engineering experience

Preferred Qualifications:

Prior supervisory experience directly leading and managing a teamASQ CQEStrong communication skills with the ability to collaborate at all levels and functions of the organizationDemonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actionsUnderstanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211)Pragmatic data driven risk-based decision maker with strong problem-solving abilityCollaborative and motivated team player. Always looking to share and advance best practicesExperience with relevant data analysis software (i.e., Minitab)Black Belt or Green Belt certificate Master's degreeAdditional Leadership experience in an FDA regulated environment (pharmaceutical, biotechnology, or medical device)Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)

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