Assistant Manager Quality (Medical Devices)

Company: Leading Medical Devices Manufacturing Company

Position: Assistant Manager – Quality

Department: Quality Assurance / Quality Control

Industry: Medical Devices / Healthcare Manufacturing

Max CTC - 10 to 12 Lakhs

Job Summary

We are looking for an experienced Quality Assistant Manager to oversee Quality Assurance and Quality Control activities in a medical devices manufacturing environment. The candidate will be responsible for maintaining quality management systems, ensuring regulatory compliance, managing audits, driving continuous improvement and ensuring that products meet applicable medical device quality and safety standards.

Key Responsibilities

- Manage day-to-day Quality Assurance (QA) and Quality Control (QC) activities.
- Ensure compliance with ISO 13485, ISO 9001 and applicable medical device regulatory requirements.
- Implement and maintain Quality Management Systems (QMS).
- Handle internal audits, external audits and customer audits.
- Coordinate with regulatory affairs for compliance with applicable medical device regulations.
- Monitor incoming material inspection, in-process inspection and final product inspection.
- Manage non-conformities, CAPA (Corrective and Preventive Actions) and root cause analysis.
- Prepare and maintain quality documentation, SOPs, work instructions and inspection reports.
- Ensure process validation, product validation and equipment qualification wherever applicable.
- Monitor customer complaints, product failures and quality-related issues.
- Drive continuous improvement initiatives to reduce rejection, rework and customer complaints.
- Coordinate with Production, Engineering, R&D; and Regulatory Affairs teams.
- Ensure calibration and maintenance of measuring instruments and testing equipment.




- Monitor supplier quality performance and conduct supplier audits.
- Lead and develop the quality team to achieve organizational quality objectives.

Required Technical Skills
- Strong knowledge of ISO 13485 – Medical Devices Quality Management System.
- Knowledge of ISO 14971 – Risk Management for Medical Devices.
- Understanding of GMP and applicable medical device regulatory requirements.
- Knowledge of CAPA, 8D, FMEA and Root Cause Analysis.
- Experience in internal, external and customer audits.
- Knowledge of IQ, OQ and PQ validation.
- Expertise in incoming, in-process and final quality inspection.
- Knowledge of documentation control and change management.
- Familiarity with regulatory requirements such as CDSCO, US FDA 21 CFR Part 820 / QMSR and CE marking requirements, depending on product markets.

Educational Qualification
- BE / B.Tech / Diploma in Mechanical, Electrical, Electronics, Biomedical or related engineering disciplines.
- Additional certification in Quality Management / ISO 13485 Lead Auditor will be an advantage.

Experience
- 5–8 years of experience in Quality Assurance / Quality Control.
- Minimum 2–3 years of experience in a supervisory or team-handling role preferred.
- Experience in medical devices manufacturing is mandatory.
- Experience in handling ISO 13485 audits and regulatory compliance is preferred.

Key Competencies
- Solid leadership and team management skills.
- Excellent analytical and problem-solving abilities.
- Good documentation and audit management skills.
- Strong communication and cross-functional coordination.
- Ability to manage quality issues and drive corrective actions.
- Focus on regulatory compliance and continuous improvement.

Thanks and Regards

L Sainath Jayaram

SAI HR CONSULTANTS

DIRECTOR TALENT ACQUISITION

(phone hidden)

[email protected]

📌 Assistant Manager Quality - Medical Devices & Regulatory Devices (Chennai)
🏢 SAI Hr Consultants
📍 Chennai