W2 only, no C2C or 3rd party
The candidate will be responsible for supporting activities related to Medical Device Coding for Complaints and bring strong knowledge of Risk Management methodology as it relates to project planning. Ideal candidates will bring past experience with implementation of a new software system for quality applications (PMS system, Complaint Handling system, eQMS, eDMS, etc.). Project Management skills and titles are very important. The ideal candidate would have 5+ years in a Program/Project Management setting, although I will consider candidates with as little as ~5 years of PM experience with some experience in a Medical Device setting, although similar mixed experience is fine as well.
Product: Cardiac Rhythm and Heart Failure products
Benefits: Medical/Dental/Vision/401(k) no company match
Quality Systems Program Manager (Through April 2026 contract// Mounds View, MN):
Tops 3 Skills:
- Strong experience with Project/Program Management activities and principles (project planning, budgeting, risk mgmt., etc.) and software systems (MS Project, Smartsheet, etc.)
- Strong experience with Risk Management for post market surveillance and overall knowledge of complaints processing
- Strong experience with implementation of an electronic complaints tracking/management system
Description:
- Responsible for leading an interdepending workstream for Risk Management and Medical Device Coding for Complaint Handling and Post-Market Surveillance.
- Provide workstream ownership and collaboration with "NextGen Complaint Handling Software" Project implementation teams and other workstreams.
- Help to define and refine coding structure for future Complaint Handling process and Software in alignment with Risk Management to drive efficiencies/automation and compliance.
- Help define and implement a compliant, consistent, and efficient approach for Risk Management implementation in NextGen Complaint Handling software and process.
Duties:
- 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 ensure alignment with program objectives.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Is accountable for overall program process, performance, and customer satisfaction.
Required Knowledge and Experience:
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Must Haves:
- 5+ years of previous project management experience
- Knowledge of 21CFR803, 21CFR820
- Knowledge of Medical Device Risk Management Methodology
- Understanding of Medical Device Quality Coding for Complaint Handling
Nice To Haves:
- Experience implementing software systems for Quality Applications
