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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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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).