Role Overview:
The Senior Director QA is the senior leader accountable for the company’s global Quality Management System (QMS) and overall quality performance. This role sets the quality strategy and ensures effective execution across design, manufacturing, clinical, and commercial activities in a highly regulated, growth-stage medical device environment.
Operating at both strategic and hands-on levels, the Senior Director QA ensures the QMS is robust, scalable, and inspection-ready at all. times, while enabling the business to grow at pace. The role provides clear leadership, sound judgement, and pragmatic decision-making to balance regulatory compliance with operational delivery.
Reporting to the COO, the Senior Director QA is a key member of the leadership team, acting as a trusted partner to Regulatory, R&D, Clinical, Operations, Supply Chain, and Commercial functions, with global responsibility across the U.S., EU, and other markets.
Key Responsibilities:
Quality System Leadership
* Own and continuously improve the global Quality Management System in compliance with ISO 13485.
* Ensure a sustained state of inspection readiness for FDA, Notified Bodies, and other regulators.
* Lead Management Review, internal audit programs, and quality performance metrics.
* Proactively identify and mitigate quality-related business risks.
Regulatory & Compliance Leadership
* Partner closely with Regulatory Affairs on submissions, changes, and post-market obligations.
* Ensure compliance with FDA QSR / 21 CFR 820, EU MDR, MDSAP, and other applicable global regulations.
* Own responses to regulatory inspections, audits, observations, and findings.
Manufacturing & Supplier Quality Oversight
* Oversee supplier qualification, audits, and ongoing performance management.
* Ensure effective systems for CAPA, nonconformances, complaints, and change control.
* Support manufacturing scale-up while maintaining regulatory compliance and product quality.
People & Culture
* Build, lead, and develop the Quality organization as the company scales.
* Set clear expectations, accountability, and development pathways for quality managers and teams.
* Drive a quality culture that balances compliance, speed, and pragmatism.
* Serve as a credible, trusted partner to cross-functional and executive stakeholders.
Essential Experience:
* Science or Engineering degree (or equivalent).
* 10+ years’ experience in medical device quality roles within regulated environments.
* Prior experience as Head of Quality, Senior Director, or equivalent senior quality leadership role.
* Deep working knowledge of FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, and EU MDR.
* Proven experience leading regulatory inspections and audits (FDA and/or Notified Body).
* Strong expertise across CAPA, supplier quality, complaints, and design controls.
* Demonstrated ability to operate hands-on in a growth-stage organization.
* Track record of scaling quality systems in startup or mid-sized medical device companies.
Desirable Experience:
* Experience in Class II / Class III, active or implantable medical devices.
* Experience in neuromodulation or complex electro-mechanical devices.
* Experience supporting global commercial expansion.
* Experience with MDSAP.
Skills & Capabilities:
* Practical, business-minded approach to quality and compliance.
* High integrity with strong judgement and decision-making capability.
* Able to influence and lead without unnecessary bureaucracy.
* Comfortable making decisions with incomplete information.
* Clear, confident communicator with executive presence.