If you’re looking for a medical device industry job in Chennai, the latest opening for a QMS Research Associate at Adiuvo Diagnostics Pvt. Ltd. is an excellent opportunity. This role is ideal for candidates with experience in Quality Management Systems (QMS), ISO 13485, regulatory compliance, and documentation control.
Adiuvo Diagnostics, a fast-growing healthcare innovation company, is strengthening its quality compliance operations and is now hiring talented professionals who can support QMS implementation, audits, and process improvements.
About Adiuvo Diagnostics Pvt. Ltd.
Adiuvo Diagnostics specializes in advanced, non-invasive medical diagnostic technologies that support clinicians in improved patient care. The company functions within a highly regulated environment—making QMS professionals vital to its operations.
Role: QMS Research Associate (Full-Time, On-Site)
Location: Chennai, Tamil Nadu
Reports To: CEO / COO / Head of Production
Key Responsibilities
1. QMS Documentation & Records Management
- Prepare and update SOPs, Work Instructions, Forms, and Quality Manuals.
- Maintain version control using a Document Control System.
- Manage CAPA files, training logs, and internal quality documentation.
2. Compliance & Regulatory Support
- Ensure alignment with ISO 13485, ISO 14971, USFDA, and CDSCO requirements.
- Assist in regulatory audits and submission documentation.
- Monitor changing regulatory norms and update QMS processes.
3. Internal Audits & CAPA Management
- Support internal audits across departments.
- Coordinate NCR, CAPA, and deviation reports.
- Ensure timely corrective and preventive actions.
4. Quality Data Analysis & Metrics Tracking
- Track and report KPIs: NCR trends, calibration schedules, audit findings, training compliance.
- Prepare reports for management review meetings.
5. Training & Cross-Functional Coordination
- Manage QMS-focused training sessions for employees.
- Collaborate with R&D, Manufacturing, Operations, and QA teams.
- Guide new hires on QMS procedures.
6. Risk Management Support
- Assist in maintaining Risk Management Files (RMF).
- Support FMEA activities and hazard identification.
- Participate in design and development risk assessments.
Required Qualifications & Skills
- Bachelor’s/Master’s in Biotechnology, Biomedical Engineering, Microbiology, Life Sciences, or related field.
- 1–3 years of experience in QMS, Quality Assurance, or Regulatory roles (medical devices preferred).
- Knowledge of ISO 13485, ISO 14971, USFDA, and CDSCO regulations.
- Strong documentation, organization, and communication skills.
- Ability to work cross-functionally and follow structured processes.
Preferred Skills (Added Advantage)
- Internal auditing experience (ISO 13485).
- Exposure to design and development workflows in regulated environments.
- Familiarity with QMS software/document control systems.
- Understanding of GMP and medical device manufacturing.
Benefits of Working at Adiuvo Diagnostics
- Opportunity to work in an innovative MedTech environment.
- Exposure to global regulatory frameworks (USFDA, ISO 13485).
- Hands-on experience with audits and QMS systems.
- Strong learning curve and cross-functional collaboration.
How to Apply
