Ui Ux Design Jobs 2026 (Now Hiring) – Smart Auto Apply
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Design Quality Engineer
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Overview
Job Description
- Ensure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle.
- Participate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items).
- Review and approve design inputs, outputs, and technical documentation.
- Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
- Ensure Design Verification & Validation (V&V) activities meet requirements.
- Review and approve, Engineering Change requests/Orders (ECR/ECOs).
- Ensure design changes follow proper change control processes.
- Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
- Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
- Design transfer to manufacturing, ensuring process readiness.
- Guide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated.
- Facilitate FMEA (Design and Process) and hazard analysis.
- Ensure risk controls are implemented, verified, and documented.
- Ensure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance.
- Record, manage, and execute CAPA processes including root cause analysis and implementation of solutions.
- Contributes to the development, implementation, and revision of QMS processes.
- Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
- Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc
- Change Management (Including design and Manufacturing transfer).
- Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk.
- You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
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