Job Title: QA Manager – Production

Location: Ernakulam, Kerala

Job Type: Full time

Department - Quality Assurance & regulatory affairs (QARA)

Experience: 5–8 years

Salary: ₹8–12 LPA

Job Summary

We are looking for an experienced QA Manager – Production to lead Quality Control activities. The role involves ensuring product quality, regulatory compliance and effective quality processes in line with ISO 13485:2016 and the Medical Devices Rules, 2017.

Key Responsibilities

- Lead incoming, in-process and final inspection and testing activities.
- Establish and maintain inspection plans, sampling procedures and quality documentation.
- Manage supplier quality, incoming material inspection and supplier audits.
- Review batch records and ensure proper product testing and release.
- Oversee calibration, validation, ESD controls and non-conforming product management.
- Lead root cause analysis, CAPA and continuous improvement initiatives.
- Ensure compliance with ISO 13485,



Indian Medical Devices Rules and applicable quality standards.
- Support internal audits, regulatory inspections and customer audits.
- Lead, train and develop the QC team.

Qualifications & Experience

- B.E./B.Tech in Biomedical, Electronics, Instrumentation or Electrical Engineering, or M.Sc. in Electronics/Physics.
- 5–8 years of experience in Quality Control, preferably in medical device manufacturing.
- Minimum 2-3 years in a supervisory or managerial role.
- Strong knowledge of ISO 13485:2016, Indian MDR 2017, ISO 14971 and ISO 2859-1.
- Experience in CAPA, root cause analysis, quality tools and audit management.
- Good communication, analytical and team-management skills.

Interested candidates can apply with their updated resume. Pay: ₹800,000.00 - ₹1,200,000.00 per year

Work Location: In person

📌 QA Manger - Production (Kochi)
🏢 Gadgeon Medical Systems
📍 Kochi