Quality Systems Program Manager (6 month contract// Minneapolis, MN):
On site 3 days per week (Tuesday/Wednesday mandatory, plus choose Monday, Thursday, or Friday as 3rd day in office)
HM's Top Needs:
- Experience with Program Management for Design Controls, Risk Management and Quality Systems for FDA PMA approved or 510(k)-cleared products.
- Developing budget / resource planning for deliverables
- Excellent team management skills, leading a team as an individual contributor
Education Required: Bachelor Degree in Engineering, Sciences
Years’ Experience Required: 8+ years
Description:
This role’s primary responsibility will be to lead a program that involves transferring medical devices from one business unit to another. It will include gap assessments for products and the quality management system to determine if any remediation of records will be required. It involves creating a Quality Plan to document project activities and to identify resources to perform those activities.
Primary Responsibilities:
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
- Prepares reports and/or necessary documentation (i.e., Quality Plans) and provides to applicable stakeholders, both internal and external
- Ensures the quality assurance programs and policies are maintained and modified regularly
