– Assistant Manager – Quality Assurance (Medical Devices)

- Department: Quality Assurance

- Designation: Assistant Manager – QA

- Industry: Medical Devices / Healthcare Manufacturing

- Location: Gandhinagar, Gujarat

- Experience: 6–10 Years

- Qualification: B.E./B.Tech./M.Sc./B.Pharm./M.Pharm. or equivalent, preferably in a relevant technical discipline.

Key Responsibilities

- Manage day-to-day Quality Assurance activities for medical device manufacturing and ensure compliance with the company’s Quality Management System.

- Ensure compliance with ISO 13485, applicable MDR requirements, GMP principles, and internal quality procedures.

- Monitor and maintain QMS processes, procedures, SOPs, work instructions, and quality records.

- Handle NCR, CAPA, deviation, change control, complaints, and quality improvement activities.

- Conduct Root Cause Analysis (RCA) using appropriate tools such as 5 Why, Fishbone, etc.

- Coordinate and support internal, customer, certification and regulatory audits.

- Ensure timely closure of audit observations, NCRs, CAPAs and other quality-related actions.

- Review and approve quality documents, inspection reports, validation protocols/reports and related records as per defined authorization.

- Coordinate with Production, R&D;, Engineering, Regulatory, Purchase and Supply Chain for quality-related issues.

- Monitor incoming,



in-process and final inspection activities and ensure adherence to defined specifications.

- Support process validation, equipment qualification, cleaning validation and other validation activities, wherever applicable.

- Participate in risk management activities such as PFMEA, Risk Analysis and risk-based decision-making.

- Ensure proper handling and investigation of customer complaints and product quality issues.

- Establish and monitor Quality KPIs, trends and quality performance reports.

- Identify recurring quality issues and drive continuous improvement projects to reduce rejection, rework, deviations and customer complaints.

- Train and guide QA/QC team members on QMS requirements, SOPs, documentation and quality practices.

- Ensure proper control, traceability, retention and retrieval of quality records and documentation.

- Support management in preparing for regulatory inspections and certification audits.

Key Competencies

- Strong knowledge of ISO 13485

- Positive understanding of Medical Device QMS and regulatory requirements

- CAPA / NCR / Deviation Management

- Root Cause Analysis &
- Problem Solving

- Change Control

- Risk Management / Risk Analysis

- Internal &

- External Audit Management

- Process &

- Product Validation

- Quality Documentation &

- Record Control

- Supplier Quality / Incoming Quality

- Complaint Handling

- Statistical / Trend Analysis

- Continuous Improvement

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