Director of Quality

Director of Quality | Medical Devices | ISO 13485 | FDA

Working Model: Hybrid – 3 days onsite per week

We are currently supporting a confidential search for a Director of Quality to join a growing healthcare technology company in Colorado.

The company develops and manufactures innovative medical and healthcare products, with a strong focus on quality, patient impact and continuous improvement. This is a highly culture-driven organisation, where collaboration, ownership and doing the right thing are genuinely important to how the business operates.

This is a key leadership position with responsibility for the company's Quality and Regulatory activities, as well as driving improvements across manufacturing, processes and the wider Quality Management System.

Key Responsibilities

• Lead and develop the Quality function and provide strategic and hands-on quality leadership.
• Own and maintain the ISO 13485 Quality Management System.
• Ensure ongoing compliance with FDA requirements and applicable medical device regulations.
• Lead quality and process improvement projects across manufacturing and operations.
• Oversee CAPA, non-conformances, deviations, complaints, root-cause investigations and corrective actions.
• Lead internal and external audits and support FDA inspections and regulatory interactions.
• Partner closely with Manufacturing, Engineering, Operations, R&D and Regulatory teams to embed quality throughout the organisation.
• Develop and improve quality processes, procedures, controls and documentation.
• Establish and monitor quality KPIs, identify risks and drive continuous improvement.
• Support new product development, manufacturing transfer and process validation from a quality perspective.
• Provide quality and regulatory guidance to cross-functional projects and senior leadership.

About You

We are looking for an experienced Medical Device Quality professional with a strong combination of Quality, Regulatory and manufacturing experience.

You should have:

• Proven experience working within ISO 13485 medical device environments.
• Strong knowledge of FDA regulations and requirements.
• Experience with FDA inspections, audits and regulatory interactions.
• Strong manufacturing quality experience.
• A track record of leading quality projects and implementing new processes/improvements.
• Hands-on experience with CAPA, non-conformances, complaints, deviations and root-cause analysis.
• Strong QMS and audit experience.
• The ability to work effectively across Manufacturing, Engineering, R&D, Operations and Regulatory.
• Strong leadership, communication and problem-solving skills.
• A proactive, hands-on approach and the ability to operate in a growing, fast-paced environment.

Why Join?

This is an opportunity to join a highly collaborative, culture-driven company where Quality has a genuine voice across the business. You will have significant ownership of the Quality function and the opportunity to influence processes, manufacturing quality and the company's continued growth.