Job Description

Job Description – Assistant Manager – Quality Assurance (Medical Devices)

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- Department: Quality Assurance
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- Designation: Assistant Manager – QA
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- Industry: Medical Devices / Healthcare Manufacturing
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- Location: Gandhinagar, Gujarat
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- Experience: 6–10 Years
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- Qualification: B.E./B.Tech./M.Sc./B.Pharm./M.Pharm. or equivalent, preferably in a relevant technical discipline.
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Key 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.
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- Ensure compliance with ISO 13485, applicable MDR requirements, GMP principles, and internal quality procedures.
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- Monitor and maintain QMS processes, procedures, SOPs, work instructions, and quality records.
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- Handle NCR, CAPA, deviation, change control, complaints, and quality improvement activities.
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- Conduct Root Cause Analysis (RCA) using appropriate tools such as 5 Why, Fishbone, etc.
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- Coordinate and support internal, customer, certification and regulatory audits.
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- Ensure timely closure of audit observations, NCRs, CAPAs and other quality-related actions.
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- Review and approve quality documents, inspection reports, validation protocols/reports and related records as per defined authorization.
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- Coordinate with Production, R&D;, Engineering, Regulatory, Purchase and Supply Chain for quality-related issues.
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- Monitor incoming,



in-process and final inspection activities and ensure adherence to defined specifications.
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- Support process validation, equipment qualification, cleaning validation and other validation activities, wherever applicable.
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- Participate in risk management activities such as PFMEA, Risk Analysis and risk-based decision-making.
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- Ensure proper handling and investigation of customer complaints and product quality issues.
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- Establish and monitor Quality KPIs, trends and quality performance reports.
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- Identify recurring quality issues and drive continuous improvement projects to reduce rejection, rework, deviations and customer complaints.
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- Train and guide QA/QC team members on QMS requirements, SOPs, documentation and quality practices.
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- Ensure proper control, traceability, retention and retrieval of quality records and documentation.
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- Support management in preparing for regulatory inspections and certification audits.
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Key Competencies

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- Solid knowledge of ISO 13485
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- Good understanding of Medical Device QMS and regulatory requirements
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- CAPA / NCR / Deviation Management
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- Root Cause Analysis & Problem Solving
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- Change Control
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- Risk Management / Risk Analysis
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- Internal & External Audit Management
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- Process & Product Validation
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- Quality Documentation & Record Control
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- Supplier Quality / Incoming Quality
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- Complaint Handling
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- Statistical / Trend Analysis
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- Continuous Improvement
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📌 Assistant Quality Assurance Manager (Lapkaman)
🏢 SLTL Group - Medical Division
📍 Lapkaman