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# Design Quality Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Bothell, WA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis
- **Published:** September 27, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=84b2a23892c49543

## About the Role

* 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.

## Description

Design Control:

 * 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.

Risk Management Support:

 * 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.

QMS Support (Audit, CAPA):

 * 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.