Sr. Program Manager Quality Systems
$142,000–$244,950 year
On-site · Santa Clara, California, United States
Job Summary
Sr. Program Manager Quality Systems leads multiple quality system programs and projects to optimize processes and support business objectives while ensuring compliance. Responsible for driving QMS optimization, implementing updates for new regulations and market expansion, coordinating external standards programs with platform partners, guiding digital transformation initiatives (including automation and AI), coordinating QA activities for audits/inspections, mentoring project teams on quality system requirements, and promoting a culture of regulatory adherence across the organization. On-site role in Santa Clara, CA with up to 20% travel; collaboration across cross-functional partners to drive quality system strategy and execution.
Required Qualifications
- Bachelor’s degree in Engineering and/or a Scientific discipline (required)
- Minimum 8-10 years of related experience in Quality Assurance or Quality System Compliance for development/manufacturing
- Experience implementing FDA QSR and ISO 13485 requirements
- Knowledge of GMPs, GDPs, and Data Integrity
- Strong communication, organizational, analytical and problem-solving skills
- Experience managing programs and leading teams (3-5 years)
- Understanding of Quality Management System applications to medical devices and related standards
- Knowledge of design controls and risk management in medical devices (preferred)
- Experience with AI solutions or process automation (preferred)
- Ability to coordinate audits/inspections (FDA/Notified Bodies)
- On-site requirement in Santa Clara, CA; travel up to 20%
Additional Requirements
- On-site in Santa Clara, CA; relocation not offered
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