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# Design Quality Engineer

- **Company:** Novintix Inc
- **Location:** Pocopson, PA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Agile Methodology, Windchill
- **Published:** September 27, 2026
- **Apply:** https://www.disabledperson.com/jobs/75541381-design-quality-engineer

## About the Role

* Bachelor's/Master's in Biomedical, Mechanical, or related engineering discipline.
 * 5-8 years of Design Quality Engineering experience in the medical device industry.
 * Strong understanding of DHF, DMR, DHR, and design control processes.
 * Experience with QMS migration, DHF remediation, or design transfer.
 * Solid knowledge of ISO 13485, 21 CFR 820, EU MDR.
 * Hands-on experience in risk management (ISO 14971), V&V, and change management.
 * Excellent documentation, analytical, and communication skills.

PREFERRED SKILLS:

 * Experience with eQMS (Agile, Windchill, etc.).
 * Six Sigma Green Belt or similar.
 * Experience in multi-site/global product lifecycle projects.

## Description

* Execute DHF and QMS migration activities.
 * Ensure design documentation, risk files, V&V reports meet regulatory and QMS standards.
 * Review & approve design control documents with complete traceability.
 * Support DHF remediation and document consolidation.
 * Collaborate with R&D, Regulatory, Manufacturing & Quality teams for smooth design transfer.
 * Identify and close gaps per ISO 13485, FDA 21 CFR 820 & EU MDR requirements.
 * Support audit preparation and inspection readiness.
 * Participate in change control and assess regulatory/quality impact.
 * Ensure alignment with internal quality systems and regulatory expectations.


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