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# Senior Design Quality Engineer

- **Company:** Page Michael International Inc
- **Location:** Moorestown, NJ, United States
- **Experience:** Expert
- **Salary:** $140,000.0
- **Contract:** Permanent contract
- **Skills:** Document Management Systems, Failure Mode Effects Analysis, Statistics Packages, Mdsap
- **Published:** August 8, 2026
- **Apply:** https://www.michaelpage.com/job-detail/senior-design-quality-engineer/ref/jn-062026-7036013?ng-src=other-users-applied&ng-jn=job-search

## About the Role

* Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).
 * 5+ years of experience in Design Quality, Quality Engineering, or related roles within the medical device industry.
 * Strong knowledge of design controls and product development processes.
 * Deep understanding of ISO 13485 requirements.
 * Experience with risk management standards (ISO 14971).
 * Familiarity with verification & validation methodologies and statistical analysis tools.
 * Experience with CAPA systems, change control, and document management systems.

## Description

The key responsibilities of the Senior Design Quality Engineer are:

 * Serve as the Quality representative on cross-functional product development teams.
 * Ensure compliance with design control procedures (e.g., FDA 21 CFR Part 820, ISO 13485).
 * Review and approve design documentation, including design inputs, outputs, verification, validation, and design transfer activities.
 * Support the development and maintenance of Design History Files.
 * Lead and support risk management activities in accordance with ISO 13485:2016, 21 CFR Part 820 and MDSAP
 * Facilitate risk assessments including FMEA/FMECA, hazard analyses, and risk/benefit evaluations.
 * Ensure risk controls are effectively implemented, verified, and documented
 * Collaborate with Manufacturing and Operations to ensure smooth design transfer and process readiness.
 * Review production specifications, process validations, and inspection criteria.
 * Support process validation activities and ensure quality requirements are maintained in production.


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