Location: Andover MA
Duration: 10 months part time 20 hours a week and as needed
10-15 years professional experience.
Education: Bachelor's /Master's degree with proven experience.
Guide and participate in MDR validation, risk assessment, requirement development, protocol and validation report writing.
Expertise in software validation for medical devices within manufacturing environment.
Guide and participate in bug testing, identification, and problem solving.
Responsible for driving compliance activities, tracking progress and resolving issues with Program Managers for MDR compliance for several products.
Other duties include:
Establish the necessary processes
Minimize the risks and fulfil general requirements
Position reports to the Program Management Office Director.