*JOB DESCRIPTIONSenior Quality Engineer – Medical Devices*

Department: Quality Assurance / Quality Control
Designation: Senior Quality Engineer
Experience: 4–8 Years
Industry: Medical Devices / Healthcare Manufacturing
Location: Hyderabad, Telangana
Employment Type: Full time
Reporting To: Quality Manager / QA Manager

*Job Summary*

We are looking for an experienced Senior Quality Engineer with strong experience in the medical device industry and hands-on knowledge of ISO 13485 requirements. The candidate will be responsible for maintaining and improving the Quality Management System (QMS), ensuring product and process compliance, handling quality issues, supporting audits, and driving continuous improvement across manufacturing operations.

*Key Responsibilities*
- Maintain and implement the Quality Management System (QMS) in accordance with ISO 13485 and applicable medical device regulatory requirements.
- Monitor and ensure compliance with approved SOPs, Work Instructions, specifications, drawings, and quality standards.




- Perform in-process and final inspections of medical device components and finished products.
- Review and approve Batch Manufacturing Records (BMR), Device History Records (DHR), inspection reports, and quality records.
- Handle Non-Conformances (NCR), CAPA, deviations, complaints, and quality incidents.
- Conduct Root Cause Analysis (RCA) using tools such as 5 Why, Fishbone/Ishikawa, Pareto analysis, and 8D.
- Lead and support CAPA investigations and monitor effectiveness of corrective and preventive actions.
- Participate in internal, customer, certification, and regulatory audits.
- Support ISO 13485 surveillance and certification audits and ensure timely closure of audit observations.
- Prepare and maintain quality reports, inspection records, trend analysis, and quality metrics.
- Monitor process performance and identify opportunities for continuous improvement and defect reduction.
- Support process validation, equipment qualification,

📌 Senior QA Engineer (Hyderabad)
🏢 SREE GURU PRECISION MANUGACTURING SOLUTIONS OPC PVT.LTD(SGMPS)
📍 Hyderabad