Job DescriptionJob Description – Assistant Manager – Quality Assurance (Medical Devices)
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- Department: Quality Assurancen
- Designation: Assistant Manager – QAn
- Industry: Medical Devices / Healthcare Manufacturingn
- Location: Gandhinagar, Gujaratn
- Experience: 6–10 Yearsn
- Qualification: B.E./B.Tech./M.Sc./B.Pharm./M.Pharm. or equivalent, preferably in a relevant technical discipline.n

nKey Responsibilities
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- Manage day-to-day Quality Assurance activities for medical device manufacturing and ensure compliance with the company's Quality Management System.n
- Ensure compliance with ISO 13485, applicable MDR requirements, GMP principles, and internal quality procedures.n
- Monitor and maintain QMS processes, procedures, SOPs, work instructions, and quality records.n
- Handle NCR, CAPA, deviation, change control, complaints, and quality improvement activities.n
- Conduct Root Cause Analysis (RCA) using appropriate tools such as 5 Why, Fishbone, etc.n
- Coordinate and support internal, customer, certification and regulatory audits.n




- Ensure timely closure of audit observations, NCRs, CAPAs and other quality-related actions.n
- Review and approve quality documents, inspection reports, validation protocols/reports and related records as per defined authorization.n
- Coordinate with Production, R&D;, Engineering, Regulatory, Purchase and Supply Chain for quality-related issues.n
- Monitor incoming, in-process and final inspection activities and ensure adherence to defined specifications.n
- Support process validation, equipment qualification, cleaning validation and other validation activities, wherever applicable.n
- Participate in risk management activities such as PFMEA, Risk Analysis and risk-based decision-making.n
- Ensure proper handling and investigation of customer complaints and product quality issues.n
- Establish and monitor Quality KPIs, trends and quality performance reports.n
- Identify recurring quality issues and d

📌 Assistant Quality Assurance Manager (Ahmedabad)
🏢 SLTL Group - Medical Division
📍 Ahmedabad