Director of Quality
We are working with a small to mid-sized surgical robotics and medical device company developing innovative robotic-assisted surgical systems. As the company scales its clinical and commercial footprint, it is seeking a Director of Quality to lead and build its Quality function.
The ideal candidate has experience scaling Quality Systems in small to mid-sized medical device environments and is comfortable operating both strategically and hands-on.
Essential Functions
- Lead and scale the Quality Management System (QMS) in compliance with FDA, ISO 13485, ISO 14971, and global regulations.
- Provide quality leadership across R&D, Manufacturing, Clinical, Regulatory, and Supply Chain teams.
- Oversee SOPs and controlled documentation.
- Lead internal, supplier, and regulatory audits; serve as primary quality contact during inspections.
- Drive CAPA, nonconformance, complaint handling, and risk management activities.
- Build and mentor the Quality team while remaining hands-on as needed.
Skill Requirements
- Proven leadership in fast-paced, resource-lean medical device environments.
- Strong knowledge of FDA QSR and ISO standards.
- Experience with surgical robotics or complex electro-mechanical medical devices.
- Excellent communication and cross-functional collaboration skills.
- Ability to manage multiple priorities in a growing organization.
If you have experience leading Quality functions in small to mid-sized medical device or surgical robotics companies, we encourage you to apply.
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