Responsibilities: + Perform all work in compliance with company policy and within the guidelines of its Quality System. + 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 + Assist teams with investigation methodologies and validation strategies + Author non-conformance reports. + Coordinate investigation activities cross-functionally. + Ensure timely non-conformance processing. + Assist teams with notes, action item recording and follow through, and communication to senior leaders as needed. + Participate in technical review discussion as a QA representative. + Coach engineering and support teams on QA tools and processes. + Serve as a Quality representative for disposition and decision-making. + Communicate complex information both verbally and in writing. + Participate in root cause investigations. + Document notes, record and follow-up on action items, and communication to senior leaders as needed. 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 + Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below. + Previous experience in an Engineering, Scientific or Investigative role is preferred. + Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred. + Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus . + 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 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.