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 good documentation practices.
- Prepare and present quality performance reports to management.
- Ensure compliance with Good Documentation Practices (GDP) and document control requirements.
Required Skills & Experience
- Strong hands-on experience in ISO 13485:2016.
- Experience in medical device manufacturing is mandatory.
- Knowledge of CAPA, NCR, 8D, RCA, Change Control, Risk Management, and Internal Audits.
- Good understanding of QMS documentation and compliance requirements.
- Experience in handling customer, certification, and regulatory audits.
- Strong analytical, problem-solving, communication, and leadership skills.
- Ability to manage a Quality team and coordinate with cross-functional departments.
Job Type: Full-time
Pay: ₹40,000.00 - ₹50,000.00 per month
Benefits:
- Commuter assistance
- Health insurance
- Provident Fund
Work Location: In person
