Sr Quality EngineerKatalyst CRO • Bellevue, WA, US
Sr Quality Engineer
Katalyst CRO • Bellevue, WA, US
1 day ago
Job type
- Full-time
Job descriptionB.S. / M.S. in Biomedical, Software, Electrical Engineering, or related field. 8+ years of progressive Quality Engineering experience in the medical device industry (hardware and software). Strong knowledge of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366. Proven expertise in design, development, verification, validation, and testing of medical devices. Skilled in statistical tools, quality engineering methods, and data analysis. Excellent communication, problem-solving, and project management skills. ASQ CQE, Six Sigma Black / Green Belt, experience with SaMD, AI / ML, AAMI TIR45, and cloud-based infrastructures. Mid-Senior level Contract Quality Assurance Industries : Pharmaceutical Manufacturing
Overview
Sr Quality Engineer role at Katalyst CRO
Responsibilities
- Lead Quality Engineering activities in new product development (design control, risk management, verification / validation).
- Develop and maintain the Risk Management File (RMF) and Design History File (DHF).
- Provide statistical guidance for design verification, validation, and test method validation.
- Act as SME for software quality, including code reviews, software security, and BOM management.
- Support product design transfer, production, and remediation of anomalies (bugs, cybersecurity vulnerabilities).
- Drive Quality System updates, CAPA resolution, and quality support for released products.
Requirements
Seniority level
Employment type
Job function
Location : Bellevue, WA
Salary : $128,600.00-$213,600.00
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Sr Quality Engineer • Bellevue, WA, US
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