Design Quality Engineer

2 weeks ago

Coimbatore, Tamil Nadu, India NovintiX Full time ₹ 12,00,000 - ₹ 24,00,000 per year

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.
  • 5–8 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.

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