Quality Assurance Executive (Medical Device)

Job Summary:

Seeking a detail-oriented Quality Assurance Executive responsible for managing and maintaining the Quality Management System (QMS) in compliance with ISO 13485:2016. The role involves QMS documentation, design control documentation, supplier quality management, SOP drafting, and support for design transfer activities.

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:

Bachelors degree in:

Biomedical / Electronics / Mechanical / Quality

Prior Experience in Medical Device Industry:

25 years