Quality Assurance Executive (Medical Device)

Job Summary:Seeking a detail-oriented Quality Assurance Executive responsible for managing and maintaining the Quality Management System (QMS) in compliance with ISO 13485:2016. The role involves QMS documentation, design control documentation, supplier quality management, SOP drafting, and support for design transfer activities.Key Responsibilities:1. QMS:· Maintain and improve QMS as per ISO 13485:2016· Generate and control QMS documents· Ensure compliance with procedures and regulatory requirements· Support internal/external audits2. Documentation & Records· SOPsi. Work Instructionsii. Forms & Templatesiii. Quality Manuals· Control of documents & records· Change management3. Design Control Documentation· Prepare and Maintaini. Design & Development Planii. Design Inputs / Outputsiii. Design Verification / Validationiv. Design Review Recordsv. DHF / DMR4. Design Transfer· Prepare Design Transfer Files· Coordinate with manufacturing/production· Ensure traceability from design to production5. Supplier Quality Management· Supplier qualification & evaluation· Supplier audits / assessments· Supplier agreements & quality clauses· Incoming inspection processes6. Compliance:· Assist in regulatory submissions· Support CAPA, NCR, Deviations· Support training & competency documentationRequired Qualifications:· Bachelor’s degree in:Biomedical / Electronics / Mechanical / Quality· Prior Experience in Medical Device Industry:2–5 years

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