About the Role:
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'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.
Required Skills:
Experience with eQMS (Agile, Windchill, etc.).Six Sigma Green Belt or similar. Experience in multi-site/global product lifecycle projects.
