Support site Quality Management System (QMS) and ensure compliance of the quality system with relevant regulations, including but not limited to ISO 13485, IVDR (EU), IVDD (EU), 21 CFR part 20 and part 11, ISO 14971 and GxP.
Represent Quality on cross-functional teams to support business needs and may lead quality initiatives driving positive site Quality culture.
Prepare QS documentation and reports as needed for routing operations support, site metrics and management review.
Requirements:
Bachelor's Degree.
At least 2 years of experience in risk management/assessment (medical device), validation and data control/integrity.