Quality Systems Program Mgr - Exempt

Job Description

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:
  • Bachelor’s 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.

#ZR

Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

Company Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.