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E Solutions
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Design Quality SME (Medical Device Regularity)

Design Quality SME (Medical Device Regularity)

8 - 13 years

|

9 - 19 Lacs

Posted:1 day ago| Platform:

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Skills Required

medical devices eu mdr ifu medical device regulations iso10993-1 iso 14971-1 usfda dhfs iec 60601-1 uf d iec 62366-1 ifus risk management and meddev 2.7/4

Work Mode

Work from Office

Job Type

Full Time

Job Description

Design Quality SME

Pune

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 60601-1,ISO 14971-1,IEC 62366-1,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.

pooja.roy@esolglobal.com

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