Job Description :
Good Knowledge in the US Code of Federal Regulation (CFR) and/or European Union (EMEA) regulations in medical device and pharmaceutical manufacturing, clinical, laboratory and logistics processes as they relate to Computer System Validation (e.g. 21 CFR Parts 11, 211, 212, 820, Medical Device Directive, ISO 13485, Annex 11
Hands on experience in implementing Industry practices (e.g. GAMP, AAMI)
Good experience in requirements engineering, test environments, test cases and protocols including Installation, Operational and Performance Qualification, traceability, defect and deviation management.
knowledge of functional risk assessment processes to determine the potential impact to patient, product and regulatory compliance.
knowledge of design and development tasks and deliverables (e.g. functional and technical specifications, code review)
knowledge of software validation lifecycle tools

Client : KRG Technologies Inc