Summary
We are partnered with a rapidly scaling MedTech company at the forefront of Neurotechnology to appoint a Senior Director of Quality. This newly created role will lead the evolution of the Quality function as the organisation scales, with a focus on building robust, inspection-ready systems, developing a high-performing team, and embedding quality as a true business partner. Reporting to the COO, this is a senior, on-site leadership role with global scope across the U.S. and Europe.
Key Responsibilities
* Set and execute the global quality strategy to support business growth and increasing organisational maturity.
* Own and continuously improve the Quality Management System in line with FDA, ISO 13485, and EU MDR requirements.
* Ensure sustained inspection readiness while maintaining practical, scalable quality processes.
* Lead, mentor, and develop a growing Quality organisation, including upskilling middle management.
* Oversee quality operations, quality programmes, and supplier/manufacturing quality activities.
* Act as a trusted, cross-functional partner to Operations, R&D, Regulatory, and senior leadership.
* Champion a pragmatic quality culture that supports the business rather than constrains it.
Requirements
* Significant experience in medical device quality within regulated environments (FDA and EU)
* Prior experience at Head of Quality, Senior Director, or equivalent senior leadership level
* Proven track record of scaling quality systems and teams in growing MedTech organisations
* Strong background in product quality, quality systems, and operational quality (not regulatory-led)
* Experience with complex or active medical devices; Neuro or energy-based technologies preferred
* Hands-on, people-focused leader with a collaborative, low-ego leadership style
* Comfortable operating on site in a fast-paced, evolving environment (no hybrid / no visa sponsorship)
* Class II Medical Device experience.
* 10yrs experience in MedTech industry and experiencing scale with a startup.
* Science or Engineering degree.
If you are interested in learning more, please apply using the link or reach out to me directly at: raj.tamana@hartmannyoung.com