*Greetings*


*Kindly share profiles to **s...@terminalcontacts.com*
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*Only genuine profiles with a DL / Visa copy and LinkedIn profile is must*



*REQT:*



*Skills:* Validation Testing Engg with Medical Devices

*Experience: *8 years

*Location:* Brooklyn Park, MN

*Start Date: *Immediate



Validation Test Engineer with Medical devices experience



*Key skills required for the job are:*

1.       Prior medical device manufacturing background and experience
required.

2.       Experience in Test Method Validation and execution, Experience in
TMV /Gage R&R and incoming inspections and related procedures.

3.       Experience in Receiving Inspection. Use of statistical Tools for
Analysis such as Minitab etc..

4.       Process validation working knowledge, writing the test cases of
IQ/OQ/PQ protocols and execute the same in production environment.

5.       Ability to review all the protocols of IQ/OQ/PQ and provide
suggestions/solutions.

6.       Manage the execution of validation protocols and write summary
reports, etc., in assurance of timely and cost efficient completion through
specialized experience and training as necessary.

7.       Ability to review Specifications /documents /Drawings , Details
Data collection

8.       Reliability Test plan /protocols creation/ Execution

9.       Hazard Analysis / Component Design FMEA / review /verification /
Updation

10.   Track the results  with CAPA

11.   Validation documentation against production processes and systems in
compliance to internal and external requirements utilizing well developed
technical and regulatory skills.

12.   Process validation and working in a clean room environment and use of
inspection, measuring and testing equipment.

13.   Proven ability of working in a cross-functional team environment.
Demonstrated ability to effectively work cross functionally with other
departments including Operations, Product Development, QA, etc. as
necessary.

14.   Communicate significant issues or developments identified during
production, validation and qualification activities.

15.   Evaluate validation results of validation protocol executions
employing specialized experience and training.

16.   Ensure validation efforts are conducted in an appropriate and timely
manner.

17.   Ability to make independent decisions and successful track record of
influencing key stakeholders.

18.   Experience in Process FMEA/ Risk management CAPA and RCA and provide
inputs to Design team.

19.   Knowledge on ISO 13485/Part 820 / ISO 14971 will be preferred



*Kindly share the below details for quick processing:*

Full Legal Name as in Driving License/ Passport:

DOB (MM/DD/YYYY):

Current Location, City and State:

Mobile and Home Phone No:

Email ID:`

US work authorization:

Highest Educational degree:

Year of Passed-out:

Over all years of experience

Currently on a project:

Willingness to relocate across the US:

Passport Number: `

Interview Availability:

Available to join from (Availability):

Skype Id:

Expected Hourly Rate (w2/1099/c2c)





Thanks,



N. Sivakumar

813 321 5307

s...@terminalcontacts.com

Terminal Contacts LLC



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