Assistant Manager Quality - Medical Devices & Regulatory Devices

SAI Hr Consultants; Chennai; On-site; INR 1,000,000 - 1,200,000; Full time

Job summary

Leading Medical Devices Manufacturing Company seeks an experienced Quality Assistant Manager to oversee QA and QC in a medical devices production setting. You will drive QMS, ensure regulatory compliance, manage audits and CAPA, and lead a team to deliver quality products that meet safety standards.

The role requires 5–8 years in QA/QC within medical devices, with a focus on ISO13485, CAPA, and regulatory audits.

Qualifications

• BE/B.Tech/Diploma in Mechanical, Electrical, Electronics or Biomedical engineering.
• Certification in Quality Management / ISO 13485 Lead Auditor is a plus.

Responsibilities

• Manage day-to-day QA and QC activities.
• Ensure ISO 13485, ISO 9001 compliance and regulatory requirements.
• Implement and maintain QMS and CAPA program.
• Lead internal, external and customer audits.
• Coordinate with regulatory for compliance across markets.
• Oversee inspections of incoming, in-process, and final products.
• Maintain quality documentation and SOPs.
• Drive process validation and equipment qualification.

Skills

ISO 13485

ISO 14971

GMP & regulatory

CAPA & 8D

Audits (internal/external/customer)

IQ/OQ/PQ validation

Inspection (incoming/in-process/final)

Documentation control

Regulatory awareness (CDSCO, FDA, CE)

Education

BE / B.Tech / Diploma (Mechanical, Electrical, Electronics, Biomedical)

ISO 13485 Lead Auditor (advantage)

Job description

Job Description 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

• Strong 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.