Cyient is Hiring | Quality Engineer |
Position – Quality Engineer-Medical Devices
Cyient
Location – Hyderabad, Telangana
Job Description
- Ensure that product development projects and changes to existing products are conducted in compliance with Quality System Regulations like ISO 13485, ISO 14971.
- Review design control elements, Design History Files, and Technical Files for conformance to applicable requirements.
- Assist in the creation of verification and validation plans, protocols, and reports. Oversee testing and analysis for standards and product requirements compliance. Participate in cross-functional teams to develop product risk management files (risk management plan, risk assessments, DFMEA, and risk management report).
- Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques
- Prefer someone who has worked for new product development of mechanical products in the medical domain.
Skills & Experience
- DHF Remediation, ISO 13485 Medical Devices, ISO 14971 Risk Management
