Job Description
Job 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

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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

📌 Assistant Quality Assurance Manager Lapkaman
🏢 SLTL Group - Medical Division
📍 Lapkaman