Vice President of Quality Assurance, Software

Confidential

San Francisco, CA

JOB DETAILS
SKILLS
Artificial Intelligence (AI), Cross-Functional, DevOps, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, Healthcare Software, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Internet Security, Leadership, Maintain Compliance, Medical Equipment, Patient Safety, Product Lifecycle, Quality Assurance, Quality Assurance Software, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Submissions, Risk Management, Software Validation, Test Automation, Validation Testing, Willing to Travel
LOCATION
San Francisco, CA
POSTED
3 days ago

Vice President of Quality Assurance, SoftwareAbout the CompanyInnovative provider of high-quality medical devicesIndustryMedical DeviceTypePrivately HeldAbout the RoleThe Company is in search of a Vice President of Quality Assurance (Software) to take on a pivotal role in leading and scaling a global software quality organization. The successful candidate will be responsible for defining and executing the global software quality strategy in alignment with business objectives, building and leading a high-performing QA team, and ensuring compliance with a range of regulatory standards including FDA, ISO, and international guidelines. This executive will also be a key member of the leadership team, driving the evolution of the Software Quality Management System, and overseeing software verification and validation strategies, automation, continuous testing, and DevOps quality integration.Applicants must have a minimum of 12-15 years' experience in quality assurance within medical devices or software as a medical device, with at least 5 years in an executive leadership role. Deep technical and regulatory expertise is essential, including strong knowledge of IEC 62304, FDA QSR/QMSR, and ISO 13485. The role requires a leader with a proven track record in scaling QA teams, strong executive presence, and the ability to influence across engineering and product organizations. Experience in AI/ML-based medical software, a background in cybersecurity for medical devices, and familiarity with global regulatory frameworks are preferred qualifications. The ideal candidate will have a background in risk management, patient safety, and a history of successful collaboration with cross-functional teams on product lifecycle and regulatory submissions.Travel PercentLess than 10%FunctionsEngineering

About the Company

C

Confidential

American Equity Mortgage, Inc., is one of the nation’s leading mortgage lenders with a proven history of success. For 20 years we have held integrity, leadership, strength and stability making us highly respected in the industry, as well as throughout the communities we serve. We are committed to our customers by specializing in helping people save money through mortgage refinancing, debt consolidation, and home purchase loans. Our employees are continually growing with our ongoing, coaching culture, training and support along with upward mobility promoting from within our organization. Our commitment to helping others carries into social responsibility to support, assist and empower communities with our private foundation known as AEM Cares, along with our corporate giving program to help and enable charitable causes nationwide reach their goals.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Financial Services
WEBSITE
https://www.americanequity.com