Director of Quality

Maclivaro Limited; Colorado; Hybrid; USD 140,000 - 170,000; Full time

Job summary

Maclivaro Limited in Colorado seeks a Director of Quality to lead and own the Quality function within a healthcare technology environment. This hybrid role combines on-site and remote collaboration to embed quality across manufacturing, engineering, operations and regulatory teams, driving continuous improvement and regulatory readiness.

The successful candidate will maintain the ISO 13485 QMS, oversee CAPA and audits, support FDA inspections, and guide quality initiatives from concept through

Qualifications

• Experience in ISO 13485 medical device environments.
• Strong knowledge of FDA regulations and regulatory expectations.
• Hands-on CAPA, non-conformances, deviations and investigations.
• Proven leadership across Manufacturing, Engineering, R&D and Regulatory.

Responsibilities

• Lead and develop the Quality function and provide strategic and hands-on 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 with Manufacturing, Engineering, Operations, R&D and Regulatory teams to embed quality.
• 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.

Skills

Quality leadership

ISO 13485

FDA regulations

CAPA management

Regulatory audits

Cross-functional collaboration

Job description

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.