Job DescriptionJob Description – Assistant Manager – Quality Assurance (Medical Devices)
N
n
Department: Quality Assurance N
Designation: Assistant Manager – QA N
Industry: Medical Devices / Healthcare Manufacturing N
Location: Gandhinagar, Gujarat N
Experience: 6–10 Years N
Qualification: B.E./B.Tech./M.Sc./B.Pharm./M.Pharm. or equivalent, preferably in a relevant technical discipline. N

nKey Responsibilities
N
n
Manage day-to-dayQuality 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

📌 Hiring: Assistant Quality Assurance Manager Odhav
🏢 SLTL Group - Medical Division
📍 Odhav