Senior Manager, Quality System & Compliance (Medical Devices)

Location: San Francisco Bay Area, California, United States; hybrid

Base salary: $195,000–$250,000 per year, plus bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.

What you will do

• Lead the strategy, execution, oversight, and continuous improvement of the Quality Management System.
• Manage CAPA, document control, training, management review, internal and external audits, QMS tool validation, and supplier management.
• Act as the QMS subject matter expert and audit lead during FDA, Notified Body, and other regulatory inspections.
• Prepare the organization for U.S. and international quality compliance requirements supporting global expansion.
• Lead, mentor, and scale the QMS team while promoting a quality-first culture and data-driven accountability.
• Collaborate with R&D, Production, Regulatory, Clinical, and Product Management leaders and manage departmental resources and strategic planning.

Requirements

• Bachelor’s degree in engineering, a scientific discipline, or equivalent experience.
• 10+ years of progressive Quality experience in the medical device industry, including 5+ years in a leadership or management role.
• Expert knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
• Experience leading or serving as a key subject matter expert during FDA and Notified Body inspections.
• Strong understanding of Quality Systems and Quality Compliance, with the ability to communicate complex topics clearly.
• Experience influencing and building consensus among senior cross-functional leaders.

Nice to have

• Experience with AI/ML-driven SaMD and cloud-based medical device platforms.
• Familiarity with medical device cybersecurity standards such as AAMI TIR57 and data privacy regulations.
• Experience with global regulatory submissions, including CE Marking and PMDA.
• Experience scaling quality processes in a fast-paced, growing environment.

Culture & Benefits

• Quality-first culture supported by collaboration, mentoring, and measurable KPIs.
• Opportunity to contribute to medical technology used by patients worldwide.
• Hybrid work arrangement in the San Francisco Bay Area.
• Base salary plus bonus and equity.