Quality Assurance & Regulatory Affairs Lead

About Vessl Prosthetics
At Vessl, we’re reimagining prosthetics. Our flagship product, the Kinn Automatic Volume Management System for lower limb prosthetic sockets, uses mechanical adjustment technology to bring effortless comfort and control to people with limb difference. We will sell to prosthetists but design with amputees in mind — our mission is to empower both. Backed by cutting-edge engineering, clinical insight, and a bold vision, we’re preparing for our first product launch in late 2025.

The Role
We are seeking an experienced Quality Assurance and Regulatory Affairs Lead to develop, own, and manage Vessl’s Quality Management System (QMS), ensuring compliance across all operational, manufacturing, and post-market activities. This role will work closely with leadership, engineering, suppliers, and contract manufacturers to maintain product quality and regulatory compliance while enabling efficient production and market success.

The ideal candidate has experience in industries such as medical device, aerospace, automotive, or other regulated industries, thrives in a fast-paced start-up environment, and can balance hands-on execution with strategic process management.

Responsibilities

• Manage and maintain Vessl’s QMS in accordance with applicable regulatory requirements (ISO 14971, FDA Class 1 Medical Device, EU MDR, ISO 13485 aligned, etc.).
• Qualify, approve, and periodically audit suppliers and contract manufacturers to ensure compliance with quality and regulatory standards.
• Lead supplier onboarding, including evaluation of quality systems, capacity, and process capabilities.
• Develop and maintain quality agreements with suppliers and contract manufacturers.
• Oversee internal and supplier audits, ensuring timely closure of nonconformities.
• Support manufacturing and incoming inspection activities to verify component and product quality.
• Lead the complaint handling process, including intake, investigation, root cause analysis, and corrective/preventive actions (CAPA).
• Collaborate with engineering to assess and implement design changes, ensuring QMS and regulatory compliance.
• Support post-market surveillance activities and maintain related records.
• Ensure accurate and complete Device Master Records and Design History Files.
• Maintain up-to-date knowledge of applicable standards, regulations, and industry best practices.

Skill and Experience to Enable Success:

• Degree in engineering, quality, or a related scientific discipline; P.Eng is an asset.
• 5–10 years of experience in quality engineering within a regulated industry (medical devices preferred).
• Proven experience managing an ISO-compliant QMS.
• Demonstrated experience qualifying and auditing suppliers and contract manufacturers.
• Strong understanding of complaint handling, root cause analysis, and CAPA processes.
• Familiarity with regulatory requirements for FDA Class I medical devices and EU MDR, and internal and external audits.
• Familiarity with ISO 19011 is an asset.
• Experience with risk management (ISO 14971) and design control requirements.
• Excellent communication skills with the ability to collaborate across teams and with external partners.
• Self-starter comfortable in a small, fast-paced start-up environment.

Why Join Vessl

• Play a pivotal role in building and scaling our quality systems ahead of launch.
• Own your role — we trust our people to lead
• Flexible work environment
• Competitive compensation, benefits, and equity options
• Opportunity to grow with the company as we scale