QMS Research AssociateAdiuvo Diagnostics Pvt. Ltd. • Chennai, Tamil Nadu, India
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QMS Research Associate
Adiuvo Diagnostics Pvt. Ltd. • Chennai, Tamil Nadu, India
4 days ago
Job descriptionSupport compliance with ISO 13485, ISO 14971 (Risk Management) , and relevant medical device regulations. Assist with USFDA and CDSCO audits , submissions, and documentation readiness. Track regulatory requirements and ensure QMS updates as needed. Assist in planning and conducting internal audits for various departments. Coordinate creation, closure, and verification of CAPA , NCR , and deviation reports . Follow up with teams to ensure timely corrective actions. Track quality KPIs such as NCR trends Calibration schedules Training compliance Audit findings Support management review meetings with data summaries and reports. Coordinate QMS-related training for employees (SOP training, audits, safety, etc.). Collaborate with R&D, Manufacturing, and Operations teams to ensure QMS adherence. Help new employees understand QMS processes (induction). Assist in updating Risk Management Files (RMF) for products. Support FMEA reviews, hazard identification, and design risk assessments. Bachelor’s / Master’s in Biotechnology, Biomedical Engineering, Microbiology, Life Sciences or related field. 1–3 years of experience in QMS, QA, or regulatory domain (Medical Devices preferred). Knowledge of ISO 13485, ISO 14971 , and medical device regulations . Strong documentation and organisational skills. Ability to work cross-functionally and follow structured procedures. Excellent communication skills and attention to detail. Experience in internal audits (ISO 13485). Exposure to design & development processes in regulated environments. Hands-on experience with QMS software or document control systems. Knowledge of GMP and manufacturing workflows.
Location : Chennai
Position Type : Full-Time
Reports To : CEO / COO / Head of Production
About the Role
The QMS Research Associate will support the implementation, maintenance, and continual improvement of the Quality Management System (QMS) in alignment with ISO 13485 , USFDA , and CDSCO regulatory requirements. The role involves documentation control, data tracking, quality audits, training coordination, and ensuring compliance across R&D and manufacturing teams.
1. QMS Documentation & Records
- Prepare, review, and maintain SOPs, Work Instructions, Forms, and Quality Manuals .
- Ensure timely document revisions and control through the Document Control System.
- Maintain accurate logs of training records, CAPA files, and internal quality documentation.
2. Compliance & Regulatory Support
3. Internal Audits & CAPA
4. Quality Data & Metrics
5. Training & Cross-Functional Support
6. Risk Management
Qualifications & Skills
Preferred Skills (Good to Have)
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Research Associate • Chennai, Tamil Nadu, India
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