Title: Senior Quality Engineer (Medical Devices) Location: Seattle, Washington/Hybrid Long Term Contract Key Responsibilities New Product Development & Design Control Lead quality engineering activities throughout the product development lifecycle, ensuring compliance with design control requirements, risk management principles, and regulatory standards. Risk & Documentation Management Develop, maintain, and oversee Risk Management Files (RMF) and Design History Files (DHF) to ensure robust product documentation and audit readiness. Verification, Validation & Statistics Provide technical and statistical expertise to guide design verification, validation, and test method validation, ensuring product reliability and safety. Software Quality Leadership Act as a Subject Matter Expert (SME) for software quality. Oversee code reviews, software security assessments, and Bill of Materials (BOM) management to ensure compliance with IEC 62304 and other applicable standards. Product Transfer & Lifecycle Support Support design transfer into production, troubleshoot quality issues, and lead remediation efforts for anomalies such as bugs, cybersecurity vulnerabilities, and design deviations. Quality Systems & CAPA Drive continuous improvement within the Quality Management System (QMS). Lead or support Corrective and Preventive Actions (CAPA), ensuring timely and effective closure. Provide ongoing quality support for released products. Required Skills: Experience: Minimum 8+ years of progressive Quality Engineering experience in the medical device industry, with exposure to both hardware and software-based products. Regulatory Knowledge: Strong expertise in FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366. Technical Expertise: Proven track record in design, development, verification, validation, and testing of medical devices. Proficiency with statistical tools, data analysis, and quality engineering methodologies. Soft Skills: Excellent communication, leadership, problem-solving, and project management skills with the ability to influence cross-functional teams.
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