Quality Engineering Manager in Boulder , CO for SomaLogic
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Quality Engineering Manager
Position Summary: The Quality Assurance team is seeking a Quality Engineering (QE) Manager to lead the quality engineering activities within the overall product lifecycle of our products. Key Job Responsibilities: Establish strategic and tactical role of the QE team, and roles and responsibilities. Develop and implement design control and risk management procedures to meet requirements of 21 CFR 820 and ISO13485:2016 as well as ISO 14971:2019. Support development projects through design phases to transfer to manufacturing Support transfer projects from design into manufacturing and support the scale-up in manufacturing from pilot to full production. Support process changes and engineering pr


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