Job Description :
Position : Software Validation Engineer
Location : Andover MA / Orlando FL
Skills: validation, risk assessment, report writing etc
Client : Philips
Description :
The Software Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites. In this role, you will help provide regulatory guidance and perform project management duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards.
Requirements:
Bachelor’s degree and a minimum of 6-7 years of related CSV experience in the medical device or other FDA/ISO regulated industry
Working knowledge of 21 CFR Part 11 and GAMP 5 is a must
Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.
Government/regulatory-body Quality System auditing/inspection experience (i.e., former FDA preferred)
Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating ?exibility in prioritizing and completing tasks and communicating potential con?icts to a supervisor
Attention to detail, organized and self-driven
Solid interpersonal and communication skills
Ability to communicate effectively both orally and in writing; smart technical writing skills a must
Effective time management; able to balance multiple projects simultaneously
Open to other’s ideas and working collaboratively across functions and/or businesses throughout all levels of the organization
Strong computer and technical writing skills