Quality Systems Program Mgr - Exempt
Quality Systems Program Mgr - Exempt
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1 Vacancy
Job Description
Job Title: Quality Systems Program Manager
Client: Medical Device Manufacturing Company
Duration: 11 months with possible extension
Location: Mounds View MN 55112
Shift: 1st Shift On-site 4 days a week
Position Summary
The Quality Systems Program Manager will provide oversight and leadership in managing Field Corrective Actions (FCA) and enterprise-wide quality system processes. This role ensures compliance with internal procedures regulatory requirements and quality standards while driving continuous improvements. The position requires strong critical thinking organizational skills and the ability to collaborate across multiple operating units and regions.
Key Responsibilities
- Strategize coordinate and execute FCA plans ensuring timely alignment with quality system requirements.
- Oversee a team of associates to manage FCA processes in compliance with standards.
- Support internal and external audits representing processes and documentation effectively.
- Provide expertise on regulatory interpretation compliance and policy enforcement.
- Prepare reports corrective/preventive action documentation and legal requests for investigations.
- Lead inspection readiness audit resolutions and compliance initiatives.
- Ensure program objectives timelines and milestones are met recommending process improvements as needed.
- Communicate with internal/external stakeholders and influence cross-functional teams to drive execution.
Required Experience & Education
- Education:
- Bachelors Degree with 5 years of experience in Quality or regulated industry
- OR Advanced Degree with 3 years of related experience
- Skills:
- Strong critical thinking and problem-solving abilities
- Excellent organizational verbal and written communication skills
Additional Skills & Competencies
- Practical knowledge in leading/managing quality programs and projects.
- Ability to analyze complex problems and influence stakeholders without direct authority.
- Experience ensuring global compliance with policies quality standards and regulations.
- Capable of fostering process improvements and enabling best practice sharing across teams.
- Advanced knowledge in quality systems with an understanding of cross-functional impacts.
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Employment Type
Full-time
