Design Quality SME
2 days ago
Role :Design Quality SME
Location : Pune
Experience: 8+ Years
Working days : 5 days work form Office.
- Degree in mechanical engineering,electrical engineering,applied sciences or a related discipline;
- 8+years of professional experience in medical device regulatory Quality systems EU MDR,US FDA 510(K)and closely working R&D,Regulatory Affairs
- organizations
- Strong proven experience in simplifying/reviewing DHFs,Design requirements,IFUs,Risk management,V&V activities etc.
- Expertise in interpreting &implementing various medical device standards and guidance's,such as IEC ,ISO ,IEC ,ISO10993-1,and MEDDEV 2.7/4.
- Experience with systems for quality management,product development,and follow-up of procedures
- Knowledge and application of medical device QMS is required (e.g.,ISO 13485,MDSAP,EU MDR,Risk Management etc.)
- Ensures that appropriate Quality Plans are made that include all stages product life cycle supports Quality Plan
- Validate key design inputs like:Usability,Reliabilty,Performance,Supportability,Manufacturability,Safety,Security,Privacy,Serviceability,
- Sustainability etc.
Interested candidates kindly share your update CV
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