Summary: The Program Manager serves as the primary liaison between the company and its customers, ensuring successful execution of customer programs from new program development to operations. This role manages new program transitions, monitors ongoing operational performance, and ensures compliance with FDA, ISO 13485, and other applicable regulatory requirements. The Program Manager partners with internal functions-including Quality, Operations, Supply Chain, and Sales-to deliver outstanding customer satisfaction, operational efficiency, and continuous improvement.
Key ResponsibilitiesCustomer Relationship Management- Act as the primary point of contact for assigned customer accounts, ensuring clear communication and alignment with expectations.
- Build and maintain strong, collaborative partnerships to drive long-term satisfaction and business growth.
Program Execution & Transition- Lead onboarding and transition activities for new customer programs, ensuring documentation, quality, and regulatory compliance are met.
- Coordinate cross-functional project teams to deliver against scope, schedule, and budget.
Operational Oversight- Monitor ongoing program performance including service levels, turnaround times, and customer KPIs.
- Identify risks and proactively resolve issues, escalating as necessary to leadership.
Regulatory & Quality Compliance- Ensure program activities adhere to FDA, ISO 13485, and customer audit requirements.
- Participate in on-site customer quality and ISO audits, support corrective and preventive action planning.
Continuous Improvement- Collaborate with Operations, Engineering, and Quality teams to implement best practices and innovative solutions.
Documentation & Reporting- Maintain accurate project documentation, timelines, and status reports.
- Provide regular updates to internal leadership and customers on program progress and performance.
Job Specific Competencies- Strong communication skills - verbal, written, and presentation
- Analytical thinking, problem solving, and decision making
- Customer service orientation with ability to anticipate client needs
- Attention to detail and results orientation
- Ability to multi-task and manage competing priorities in a fast-paced environment
- Fosters teamwork and builds trust across cross-functional teams
Minimum Qualifications- Bachelor's Degree
- 3+ years of prior experience preferred
