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 valuable documentation practices.
Prepare and present quality performance reports to management.
Ensure compliance with Positive 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