Title: Program Manager
Location: Hybrid (3 Days Onsite) at Minneapolis, MN 55432
Duration: 5 Months
Pay Rate: $80-$82/hr on W2
Experience:
Experience with Program Management for Design Controls, Risk Management and Quality Systems for FDA PMA approved or 510(k)-cleared products.
2. Developing budget / resource planning for deliverables
3. Excellent team management skills, leading a team as an individual contributor
This role’s primary responsibility will be to lead a program that involves transferring medical devices from one our client business 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. The ideal candidate should have the following:
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 (example, Quality Plans) and provides to applicable stakeholders, both internal and external
Ensures the quality assurance programs and policies are maintained and modified regularly
Education Required: Bachelor Degree in Engineering, science
Years’ Experience Required: 8+ years
Responsibilities may include the following and other duties may be assigned.
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.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Co-ordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly. 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 practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. 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.
