Quality Engineer II/III-Instrument QA

Description

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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