Medical Device Quality Engineer
VirtualVocationsSouth Bend, Indiana, United Statesjob_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_description
A company is looking for a Senior Principal Software Quality Engineer.
Key Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with industry standards and regulations
Lead the development and maintenance of the Risk Management File (RMF), including risk management plans and hazards analysis
Review and approve Design History Files (DHF) and associated documentation
Required Qualifications
8+ years of progressive Quality Engineering experience in the Medical Device industry
Deep understanding of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366 standards
Experience with design, verification, validation, and testing of electromechanical medical devices and software
Proficiency in statistical tools and quality engineering tools for process improvement
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Quality Engineer • South Bend, Indiana, United States
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