Responsibilities:
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Perform all work in compliance with company policy and within the guidelines of its Quality System.
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Support the Non-conformance, CAPA, validation and risk management systems to ensure the following:
- Relevant procedures and requirements are considered and applied
- Timely completion of support activities
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Assist teams with investigation methodologies and validation strategies
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Author non-conformance reports.
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Coordinate investigation activities cross-functionally.
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Ensure timely non-conformance processing.
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Assist teams with notes, action item recording and follow through, and communication to senior leaders as needed.
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Participate in technical review discussion as a QA representative.
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Coach engineering and support teams on QA tools and processes.
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Serve as a Quality representative for disposition and decision-making.
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Communicate complex information both verbally and in writing.
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Participate in root cause investigations.
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Document notes, record and follow-up on action items, and communication to senior leaders as needed.
Qualifications:
Training and Education
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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.
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Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
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ASQ Certification (e.g., Certified Six Sigma Green Belt, CQE) a plus.
Experience
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Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
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Previous experience in an Engineering, Scientific or Investigative role is preferred.
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Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
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Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus.
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Familiarity with electromechanical and pneumatic components and systems is a plus.
Knowledge, Skills and Abilities:
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Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
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Technical writing skills
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Writing procedures, flowcharting
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Ability to collaborate cross-functionally
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Application of Quality Risk Management principles
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Attention to detail (e.g., document reviews, investigation write ups).
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High level of written and verbal communications skills
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Ability to communicate with Statisticians and perform statistical calculations as instructed
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Wisdom to seek help when needed.
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Proficiency in MS Office tools, including Outlook, Word, and Excel
Physical Requirements:
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Must be able to lift at least 25 lbs. and may be required to lift up to 50 lbs.
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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.
