Job Description – Quality Manager (for GRK Company) – Medical Devices

Position: Quality Manager
Industry: Medical Devices
Experience: 8–15 years
Qualification: B.Tech/B.E./M.Tech/M.Sc. in relevant engineering or science discipline
Location: Hyderabad

Job Summary

We are looking for an experienced Quality Manager with strong experience in the medical device industry and hands-on knowledge of ISO 13485. The candidate will be responsible for managing the Quality Management System (QMS), ensuring product and process quality, regulatory compliance, and continuous improvement.

Key Responsibilities
- Manage and maintain the ISO 13485 Quality Management System.
- Ensure compliance with applicable medical device quality and regulatory requirements.
- Plan and conduct internal audits and coordinate external/customer audits.
- Handle CAPA, NCR, deviations, complaints, and root cause analysis.
- Review and approve quality-related documents, procedures, specifications, and records.
- Monitor incoming, in-process, and final inspection activities.
- Work closely with Production, R&D;,



Engineering, and Regulatory Affairs teams to resolve quality issues.
- Establish and monitor quality KPIs and drive continuous improvement.
- Ensure proper control of non-conforming products and corrective actions.
- Support supplier qualification, supplier audits, and supplier quality improvement.
- Ensure proper implementation of change control and risk management activities.
- Participate in product/process validation and qualification activities.
- Train employees on quality procedures, QMS requirements, and good documentation practices.
- Prepare and present quality performance reports to management.
- Ensure compliance with Good Documentation Practices (GDP) and document control requirements.

Required Skills & Experience
- Robust hands-on experience in ISO 13485:2016.
- Experience in medical device manufacturing is mandatory.
- Knowledge of CAPA, NCR, 8D, RCA, Change Control, Risk Management

📌 Quality Manager (Patancheruvu)
🏢 SREE GURU PRECISION MANUGACTURING SOLUTIONS OPC PVT.LTD(SGMPS)
📍 Patancheruvu