Essential Job Duties and Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of its Quality System.

• Lead investigations into product and material non-conformances (NCR), including problem identification, product & process quality risk assessment, root cause analysis, product disposition, remedial action, and the need for follow-up action.

• Author non-conformance reports.

• Coordinate investigation activities cross-functionally.

• Ensure timely NCR processing.

• Analyze data related to product non-conformities to identify trends and emerging issues.

• Participate in technical review discussion as a QA representative.

• Coach engineering and support teams on QA tools and processes.

• Assist with equipment process validations and in process test method validations.

• Serve as a Quality representative for disposition and decision-making.

• Communicate complex information both verbally and in writing.

• Engage in managing quality risks associated with equipment and process changes.

• Facilitate root cause investigations.

• May lead teams with investigation methodologies and validation strategies.

• Document notes, record and follow-up on action items, and communication to senior leaders as needed.

• Manage small projects when assigned.

• May study, develop and report Quality related metrics.

  Qualifications:

  Training and Education

• Required – bachelor’s degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.

• Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

• ASQ Certification (e.g., Certified Six Sigma Green Belt, CQE) a plus.

  Experience

• 3+ year of experience in an Engineering, Scientific or Investigative role is required.

• Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is required.

• Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) required.

• Familiarity with electromechanical and pneumatic components and systems is a plus.

  Knowledge, Skills and Abilities:

• Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

• Technical writing skills

• Writing procedures, flowcharting

• Ability to collaborate cross-functionally

• Application of Quality Risk Management principles

• Attention to detail (e.g., document reviews, investigation write ups).

• High level of written and verbal communications skills

• Ability to communicate with Statisticians and perform statistical calculations as instructed

• Wisdom to seek help when needed.

• Proficiency in MS Office tools, including Outlook, Word, and Excel

• Developing Trends and Measures

• Project management skills

• Creating and giving training presentations

• Mentoring peers and leading groups

  Physical Requirements:

• Must be able to lift at least 25 lbs. and may be required to lift up to 50 lbs.

• Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.

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