Key Responsibilities:

1. QMS:

· Maintain and improve QMS as per ISO 13485:2016

· Generate and control QMS documents

· Ensure compliance with procedures and regulatory requirements

· Support internal/external audits

2. Documentation & Records

· SOPs

i. Work Instructions

ii. Forms & Templates

iii. Quality Manuals

· Control of documents & records

· Change management

3. Design Control Documentation

· Prepare and Maintain

i. Design & Development Plan

ii. Design Inputs / Outputs

iii. Design Verification / Validation

iv. Design Review Records

v. DHF / DMR

4. Design Transfer

· Prepare Design Transfer Files

· Coordinate with manufacturing/production

· Ensure traceability from design to production

5. Supplier Quality Management

· Supplier qualification & evaluation

· Supplier audits / assessments

· Supplier agreements & quality clauses

· Incoming inspection processes

6. Compliance:

· Assist in regulatory submissions

· Support CAPA, NCR, Deviations

· Support training & competency documentation

Required Qualifications:

· Bachelor’s degree in:

Biomedical / Electronics / Mechanical / Quality

· Prior Experience in Medical Device Industry:

2–5 years