Quality Engineer (Medical Device)
Actively Reviewing the ApplicationsTopia MedTech
Job Description
Job Summary:
Seeking a detail-oriented Quality Engineer 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:
· Bachelor’s degree in:
o Biomedical / Electronics / Mechanical / Quality
· Prior Experience in Medical Device Industry:
o 2–5 years
Required Skills
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