Job Posting: QMS Officer / Executive (Medical Devices)
Job Title: QMS Executive / Quality Management System Officer
Location: [Insert City, e.g., Delhi NCR, Bangalore, Mumbai]
Salary: Up to ₹30,000 per month (Negotiable based on experience and skillset)
Experience Level: 2–3 years of hands-on experience in Medical Device QMS
Industry: Medical Devices / Surgical Equipment Manufacturing & Distribution
About the Role
We are an innovative medical equipment company specializing in advanced surgical solutions, including orthopedic/spinal implants (pedicle screws, bone plates) and high-tech active electronic medical equipment (Surgical Navigation Systems, Intraoperative Neuro-Monitoring systems).
We are looking for a focused and detail-oriented QMS Executive with 2-3 years of experience to manage our day-to-day quality system workflows. You will be responsible for ensuring that our raw materials, sterile manufacturing processes, hardware, and medical software comply strictly with ISO 13485:2016 and CDSCO Medical Device Rules.
Key Responsibilities
- Documentation & Records Control: Maintain and update the Plant Master File (PMF), Device Master Files (DMF), Technical Files, and standard operating procedures (SOPs) for both mechanical implants and software-driven systems.
- CDSCO & Regulatory Compliance: Assist in maintaining documentation required for CDSCO MD-5/MD-6 manufacturing or MD-15/MD-16 import licenses for Class B, C, and D devices.
- CAPA & Non-Conformance Management: Log, investigate, and track floor deviations, customer complaints, and non-conformances. Coordinate root-cause analysis (5-Whys/Fishbone) and implement Corrective and Preventive Actions (CAPA).
- Production Floor Audit Support: Monitor cleanroom protocols, sterilization records, batch manufacturing records (BMR), and line clearance activities for implants like pedicle screws.
- Hardware & Software Quality Controls: Assist in managing calibration schedules for electrical components and tracking software version controls or life-cycle processes (IEC 62304) for navigation and monitoring systems.
- Internal Audits: Actively participate as an internal auditor to ensure production and engineering teams are audit-ready for third-party or regulatory inspections.
Required Qualifications & Skills
- Education: B.Pharma, M.Pharma, B.Tech/Diploma in Biomedical Engineering, Biotechnology, or a related Science stream.
- Experience: Strictly 2–3 years of experience handling documentation within a medical device manufacturing or distribution company.
- Core Competencies:
- Fundamental understanding of ISO 13485:2016 (Medical Device QMS) and ISO 14971 (Risk Management).
- Familiarity with cleanroom classifications, bioburden, and sterilization validation controls (Gamma/EtO) for surgical implants is a major advantage.
- Basic knowledge of software/hardware quality assurance for diagnostic or electronic monitoring systems.
- Good command over MS Office (Word, Excel) for flawless documentation and log-keeping.
- Clear communication skills to collaborate with internal production teams.
What We Offer
- Salary: Up to ₹30,000 / month (Final offer depends on technical interview performance and experience depth).
- Opportunity to work with a highly advanced, dual-domain portfolio (both mechanical implants and cutting-edge computerized surgical navigation).
- Professional growth in the rapidly expanding Indian medical device regulatory landscape.
Pay: ₹30,000.00 per month
Benefits:
Work Location: In person
