Please share suitable resume asap.
Designation: Validation Test Lead
Location: Danvers, MA
Duration: 6+ Months
Validation Engineer
Job Description: Validation of Engineering Tools for Medical domain
( Agile / JIRA exposure is must)
Process understanding at Customer place.
Inputs Collection.
Documents preparation for Tool validation.
Protocol Execution
Reports preparations
SOP/Work instructions preparation
Process Documents preparation / updation
Status update to the Customer and Project Manager periodically
Training on new procedures released.
Six point to describe:
Validation of Engineering tools for Medical domain ( Agile / JIRA exposure is must)
Process understanding at Customer place.
Inputs Collection.
Documents preparation for Tool validation.
Protocol Execution
Reports preparations
SOP/Work instructions preparation
Process Documents preparation / updation
| Mandatory Skills | ||
| Technical / Soft Skills | Expertise Level (Expert / Good / Knowledge) | |
| ISO13485 | Expert | |
| Agile | Expert | |
| Agile Standards | Expert | |
| JIRA | Expert | |
| IEC 62304 | Expert | |
| 21 CFR Par 11 | Good | |
| 21 CFR Part 820 | Good | |
| Varun Goel | SYSMIND, LLC | |
|
Phone: 609-897-9670 x 2166 Email: varunG@sysmind.com Website: sysmind.com Address: 38 Washington Road, Princeton Junction, NJ 08550 | |
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