onsite
QA/QC Engineer - Nilaum Healthcare
Software Engineer
QA/QC Engineer responsible for ensuring raw materials, in‑process and finished medical device products meet ISO 13485 standards through rigorous inspection, documentation and traceability. Requires strong quality control expertise and experience in medical device manufacturing.
About the role
Key Responsibilities
- Inspect incoming raw materials, in‑process and finished products to verify compliance with quality specifications and regulatory requirements.
- Maintain accurate QC inspection records, test reports, and certificates in accordance with ISO 13485 and company SOPs.
- Ensure traceability of all materials and components through documentation and record‑keeping systems.
- Collaborate with production, engineering and regulatory teams to resolve quality issues and implement corrective actions.
- Participate in internal and external audits, providing necessary documentation and supporting evidence.
Requirements
- B.Sc./M.Sc., B.Pharm, Diploma/B.E. in Engineering or related field.
- 1–2 years of experience in Quality Control, preferably in the medical device industry.
- Strong knowledge of ISO 13485 and quality management systems.
- Excellent attention to detail, analytical skills and ability to work independently.
- Effective communication skills in English and Hindi.
Skills
software developmentsystem designproblem solving