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
- Support 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.
3. Internal Audits & CAPA
- 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.
4. Quality Data & Metrics
- Track quality KPIs such as
- NCR trends
- Calibration schedules
- Training compliance
- Audit findings
- Support management review meetings with data summaries and reports.
5. Training & Cross-Functional Support
- 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).
6. Risk Management
- Assist in updating
Risk Management Files (RMF)
for products.
- Support FMEA reviews, hazard identification, and design risk assessments.
Qualifications & Skills
- 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.
Preferred Skills (Good to Have)
- 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.
