Design Quality Engineer - CRE Transfer

Key Responsibilities

• Review and approve design control documentation across all phases, ensuring complete traceability and alignment with requirements, risk controls, and applicable regulations & standards.
• Execute DHF and QMS migration activities.
• Execute DHF and QMS migration activities.
• Ensure design documentation, risk management files, and verification/validation reports comply with regulatory and quality system requirements.
• Review and approve design control documents, ensuring traceability to requirements and standards.
• Support Design History File (DHF) remediation and document consolidation efforts.
• Collaborate closely with development teams to ensure design control requirements are incorporated throughout the product lifecycle.
• Identify and resolve gaps in existing documentation per ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
• Support audits and inspection readiness related to design control and QMS compliance.
• Participate in change control activities ensuring all design changes are evaluated for quality and regulatory impact.
• Ensure alignment with internal quality standards and external regulatory expectations.
  

Qualifications & Experience

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• 58 years of experience in Design Quality Engineering within the medical device industry.
• Strong knowledge of DHF, DMR, and DHR structures and requirements.
• Proven experience in QMS migration, DHF remediation, or design transfer.
• In-depth understanding of ISO 13485, ISO14971, eQMS, Agile, Windchill, RIMS,etc.,21 CFR 820, EU MDR, and applicable global regulatory frameworks.
• Experience in risk management (ISO 14971), design verification/validation, and change management.
• Strong understanding of the full Design Control lifecycle from user needs to design transfer and changes.