Validation Test Engineer with TQ/OP/PA protocols, 21 CFR ( Must have worked win Medical Device Industry)

Please submit consultant who has worked in Medical device Industry NOT with Pharmaceutical Industry

Validation Test Engineer with TQ/OP/PA protocols, 21 CFR ( Must have worked with Medical Device Industry)
Location: Columbus, OH or Ann Arbor, MI
6-12 months
Phone followed by F2F.

We are looking for candidates that are strong in the Medical Device Industry with Software, computer systems validation and someone with experience in software engineering practices in the medical device industry. Prefer candidates stronger in the medical device than the pharmaceutical industry. write and execute IQ/OQ/PQ validation protocols, conduct tests, prepare validation reports. perform Risk Assessment, GAP analysis and remediation of Software or Computer systems

Key Skills:
IQ, OQ, PQ
FDA
21 CFR Part 11, Part 820
GAMP
Software Validation
Requirements Trace(ability) Matrix (RTM) Validation Summary Report

Have a Productive Day,

Shiva Kumar,  | e-IT Professionals Corp.
42180 Ford Rd, Suite 275| Canton, MI - 48187
Ph: (734) 416-0059 x 31 | Mobile: (734) 320 4159 | Fax: (734) 416-0010