Vice President of Quality Assurance, Software

Vice President of Quality Assurance, Software

About the Company

Innovative provider of high-quality medical devices

Industry
Medical Device

Type
Privately Held

About the Role

The 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 Percent
Less than 10%

Functions

• Engineering