*Validation Tester*

*Monmouth Junction, NJ *

*6+Months*

*Phone then Inperson*





*Responsibility *



*                 Reviews, edits current and writes new QMS procedures and
other documents as needed to meet ISO and FDA QMS requirements either
independently or with a consultant.

*                 Reviews partner QMS procedures and other documents as
requested to meet ISO and FDA QMS requirements either independently or with
a consultant.

*                 Identifies and reviews regulatory standards and shares
with teams as needed to educate the teams on QMS requirements

*                 Works with project leaders and both internal and external
(consultants) team members to ensure that all the development work on both
projects meets applicable ISO and CFR QMS requirements.

*                 Reviews all project documentation in partnership with
partner and consultant counterparts (specifications, drawings, protocols,
reports, change controls and other documentation) to confirm that the
output meets QMS requirements.



*Qualifications:*



ยท        Bachelors Degree in Mech Engineering or other Engineering or
Scientific discipline plus minimum of ten years of experience in medical
device and drug-device combination product Quality Assurance with
experience in implementing ISO and FDA compliant QMS. CQE or CQA
certifications required.





Regards,

Chetan Singh Panwar
Dominion Technology Services Corp

(804)859-7510

E-mail: [email protected]

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