Assistant Quality Assurance Manager

SLTL Group - Medical Division; Gandhinagar; On-site; INR 1,400,000 - 1,800,000; Full time

Job summary

SLTL Group - Medical Division is seeking an Assistant Manager – Quality Assurance (Medical Devices) in Gandhinagar, Gujarat. The role leads day-to-day QA activities, ensures ISO 13485 and MDR/GMP compliance, and maintains the QMS with a focus on defect prevention and continuous improvement.

The incumbent will drive RCA, NCR/CAPA handling, audit support, and cross-functional collaboration with Production, R&D, Regulatory and Supply Chain to uphold product quality and regulatory readiness.

Qualifications

• Bachelor-level or higher in a technical discipline relevant to medical devices.
• Minimum 6–10 years in quality assurance for medical devices.
• Experience with ISO 13485, MDR, GMP and related procedures.
• Strong capability in NCR/CAPA, deviation handling and change control.

Responsibilities

• Oversee daily QA activities for medical device manufacturing.
• Ensure compliance with ISO 13485, MDR, GMP, and internal procedures.
• Maintain QMS processes, SOPs, work instructions and records.
• Handle NCRs, CAPAs, deviations, complaints and quality improvements.
• Lead root cause analysis using 5 Whys, Fishbone, etc.
• Coordinate internal, customer and regulatory audits and ensure timely closure.

Skills

QA Management

GMP

ISO 13485

Audits

Education

B.E./B.Tech./M.Sc./B.Pharm./M.Pharm. or equivalent

Job description

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

• Department: Quality Assurance
• 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.
• Strong knowledge of ISO 13485
• Good understanding of Medical Device QMS and regulatory requirements