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BIOMERIEUX, INC. Quality Engineer II/III-Instrument QA in SALT LAKE CITY, Utah
Quality Engineer II/III-Instrument QA
Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality
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A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
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 and 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, incl uding Outlook, Word, and Excel * Developing Trends and Measures * Project management skills * Creating and giving... For full info follow application link.