Design Quality Engineer

We are looking for an experienced Design Quality Engineer to support a major project involving Design History File (DHF) and Quality Management System (QMS) migration activities.

Responsibilities

• 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.

Qualifications

• Bachelor’s/Master’sin 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.

Required Skills

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

If Interested apply at [email protected]

Pay: $29.40 - $35.41 per hour

Work Location: In person