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, and cleaning/sterilization validation activities where applicable.
- Review change controls and assess their impact on product quality and regulatory compliance.
- Coordinate with Production, R&D, Engineering, Regulatory Affairs, and Supply Chain teams to resolve quality-related issues.
- Support supplier qualification, supplier audits, incoming inspection, and supplier corrective actions.
- Conduct quality training for production and other functional teams on SOPs, GMP, quality requirements, and inspection procedures.
- Ensure proper control and traceability of quality documents and records.
- Monitor rejection, rework, customer complaints, process deviations, and defect trends and recommend corrective actions.
- Ensure compliance with Good Manufacturing Practices (GMP) and applicable medical device regulations.
- Participate in risk management activities in accordance with applicable standards such as ISO 14971.
- Support implementation of process improvements, quality improvement projects, and Lean/continuous improvement initiatives.
Required Qualifications
- B.E./B.Tech./Diploma in Mechanical, Biomedical, Electronics, Production, Industrial, or related engineering discipline.
- 4–8 years of relevant experience in Quality Engineering within the medical device manufacturing industry.
- Strong working experience with ISO 13485 and Medical Device QMS requirements.
- Good knowledge of GMP, CAPA, NCR, deviation, change control, complaint handling, and risk management.
- Experience in internal and external audits.
- Knowledge of root cause analysis and problem-solving methodologies.
- Good understanding of inspection methods, measuring instruments, sampling, and quality control techniques.
- Experience with process validation / equipment qualification is preferred.
- Knowledge of ISO 14971 and medical device risk management is preferred.
- Familiarity with FDA 21 CFR Part 820 / QMSR and other applicable medical device regulations is an advantage.
Technical Skills
- ISO 13485:2016
- Medical Device Quality Management Systems
- CAPA Management
- NCR / Non-Conformance Management
- Root Cause Analysis
- 5 Why / Fishbone / 8D
- Internal Quality Audits
- Supplier Quality Management
- Process & Product Inspection
- Risk Management – ISO 14971
- Change Control
- Deviation Management
- Validation & Qualification
- Statistical Process Control (SPC)
- MSA / Gauge R&R
- FMEA
- Quality Documentation
- GMP
- Supplier quality improvement
- Process defect reduction
- Compliance with QMS procedures
- Improvement in first-pass yield
- Timely completion of quality documentation
Job Type: Permanent
Pay: ₹35,000.00 - ₹45,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
