Sr. Program Manager Quality Systems
$142,000–$244,950 year
On-site · Santa Clara, California, United States
Job Summary
Sr. Program Manager Quality Systems leading multiple QMS optimization programs and cross-functional projects to streamline procedures, drive regulatory readiness, and enable digital solutions (AI-driven) across quality systems. Responsibilities include coordinating external standards programs, assessing and updating procedures, supporting FDA/Health Authority inspections, audit readiness activities, and mentoring teams to ensure compliance with GMP, GDP, and ISO requirements. The role requires governance across quality management strategy, transformation initiatives, and risk management for medical device quality programs; requires collaboration with platform partners and cross-functional partners to drive process improvements and regulatory alignment. On-site presence is required in Santa Clara, CA with up to 20% travel.
Required Qualifications
- Bachelor’s degree in Engineering and/or a Scientific discipline (minimum)
- Minimum 8-10 years of related Quality Assurance or Quality System Compliance experience
- 3-5 years of people and program management
- Strong knowledge of GMPs, GDPs, Data Integrity, FDA QSR and ISO 13485
- Experience with QA/quality systems for medical devices
- Strong communication, analytical, and problem-solving skills
- Experience leading cross-functional programs and audits
- Experience implementing AI solutions or process automation is desired
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