Senior Design QA Engineer, Medical Devices
Smith Nephew
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Benefits offered by this job
Job summary
Smith+ Nephew in United States (Pittsburgh area) seeks a Senior Design Quality Assurance Engineer to partner with cross-functional teams, ensuring quality, safety, and regulatory compliance for medical devices and software across the lifecycle.
The role emphasizes design quality, risk management, and CSV/CSA activities, with mentorship to peers and involvement in audits and investigations.
Qualifications
- Master's or bachelor's or associate degree with related QA/engineering experience.
- Strong understanding of Design Quality Assurance principles and risk management.
- Experience applying ISO 13485, ISO 14971, and IEC 62304.
- Familiarity with FDA QSR 21 CFR Part 820 and Quality System Regulations.
- Experience supporting software verification and validation.
Responsibilities
- Lead Design QA activities for new product development and design changes.
- Conduct product risk assessments including FMEA and risk management activities.
- Review and approve design inputs, specifications, and traceability.
- Review and approve software unit tests; support integration, verification, and validation.
- Execute CSV and CSA activities for Quality System tools.
- Support audits, CAPAs, non-conformances, and investigations as needed.
- Mentor engineering teams on SDLC best practices, risk management, and design control compliance.
Skills
Education
Tools
Job description
Smith+ Nephew in United States (Pittsburgh area) seeks a Senior Design Quality Assurance Engineer to partner with cross-functional teams, ensuring quality, safety, and regulatory compliance for medical devices and software across the lifecycle.
The role emphasizes design quality, risk management, and CSV/CSA activities, with mentorship to peers and involvement in audits and investigations.
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