Vice President of Quality

Vice President of Quality

About the Company

World-leading provider of an AI-powered cognitive patient care assistant

Industry
Hospital & Health Care

Type
Privately Held, VC-backed

Founded
2016

Employees
51-200

Funding
$76-$100 million

Categories

• Computer Programming
• Software
• Professional Services
• Computers
• Analytics
• Health Care
• Information Technology
• Machine Learning

About the Role

The Company is seeking a Vice President of Quality to lead the ISO 13485 certification process and establish a robust Quality Management System (QMS) integrated with engineering tools and workflows. The successful candidate will be responsible for owning the certification roadmap, designing and building the QMS, and serving as the primary liaison with certification bodies. This role requires a hands-on approach to anticipate audit risks, lead internal teams, and maintain core QMS processes. The VP of Quality will also be instrumental in driving the QMS architecture within a PLM environment, ensuring quality processes are integrated with engineering workflows, and establishing traceability between quality and engineering artifacts. Applicants must have a minimum of 10 years' quality experience in medical devices, with a strong emphasis on ISO 13485 certifications. The role demands a leader with a proven track record in building and developing quality teams, as well as expertise in hardware, software, and supply chain quality. The ideal candidate will have a deep understanding of quality standards such as 21 CFR Part 820, ISO 14971, and IEC 62304, and experience in PLM-QMS integration. Strong communication and collaboration skills are essential, as is the ability to influence across various teams and represent the quality function at the leadership level. A background in FDA inspections and experience in mentoring early-career quality professionals are also highly valued.

Hiring Manager Title
Director of QA

Functions

• Operations