Quality Director
Guided Search Partners, Vermont, WI, United States
Guided Search Partners (GSP)
Guided Search Partners is an Executive Search firm built on Trust, Transparency, Specialization, and Long-term Relationships.
We connect high-performing professionals with organizations that value people, performance, and growth—helping leaders find roles where they can make an impact and build meaningful careers.
About the Opportunity We’re partnering with a medical device manufacturer that is restructuring its quality organization and seeking a high-level Quality Director to oversee two facilities and help elevate the company’s Quality Management System. The business was acquired in 2020 and is now at a point where its quality systems need to be updated to support future growth and higher-level quality work.
This role was created because the current system is outdated and the company now needs a leader who can bring the QMS to a higher level. The right person will help rebuild the quality organization, mentor a younger team, strengthen regulatory and compliance documentation, and create the kind of quality culture the business is working toward.
What You’ll Do
Maintain and improve the Quality Management System in compliance with ISO 13485 and FDA Quality System Regulation.
Lead Management Review and internal audit programs.
Oversee document control, change control, and training systems.
Ensure regulatory compliance and inspection readiness.
Serve as the primary quality contact for regulatory bodies, including the FDA.
Lead responses to regulatory inspections and customer audits.
Oversee nonconformance management, CAPA, complaint handling, and product release and acceptance activities.
Ensure robust validation programs for equipment, processes, and software.
Lead and develop the Quality organization across multiple sites.
Build the QMS and help create the quality culture the company is building.
Provide training and guidance to cross-functional teams including engineering, manufacturing, and supply chain.
Help build the team and create a succession plan for the future.
Who You Are You are a quality leader with strong medical device experience who can step into a business that is rebuilding and provide both structure and mentorship. You understand quality systems, regulatory expectations, and compliance documentation, but you also know how to develop people and help shape culture. This role requires someone who can assess weaknesses, make the right moves, and build a stronger quality organization over time.
Preferred Experience & Attributes
Bachelor’s degree required, Master’s degree preferred.
Degree in Engineering, Life Sciences, or related field preferred.
10–15+ years in medical device quality.
5–10+ years in quality leadership.
Strong experience with ISO 13485.
Strong experience with 21 CFR Part 820.
Strong experience with QMS and CAPA.
Experience in medical device manufacturing environments.
Strong regulatory and compliance documentation experience.
Experience in a restructuring environment.
ASQ Certified Quality Engineer (CQE) preferred.
ASQ Certified Quality Manager (CMQ/OE) preferred.
Six Sigma Black Belt preferred.
Why This Role Matters The company’s quality system has been in place for decades and needs to be upgraded. The registrar has identified gaps, and the business believes the system needs to be brought to a higher level rather than rebuilt from scratch. This hire will play a central role in updating the QMS, building the right team, mentoring developing talent, and helping the business support higher-level quality work moving forward.
Reporting Structure
Reports to the Managing Director / President, Nolato Vermont.
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Guided Search Partners is an Executive Search firm built on Trust, Transparency, Specialization, and Long-term Relationships.
We connect high-performing professionals with organizations that value people, performance, and growth—helping leaders find roles where they can make an impact and build meaningful careers.
About the Opportunity We’re partnering with a medical device manufacturer that is restructuring its quality organization and seeking a high-level Quality Director to oversee two facilities and help elevate the company’s Quality Management System. The business was acquired in 2020 and is now at a point where its quality systems need to be updated to support future growth and higher-level quality work.
This role was created because the current system is outdated and the company now needs a leader who can bring the QMS to a higher level. The right person will help rebuild the quality organization, mentor a younger team, strengthen regulatory and compliance documentation, and create the kind of quality culture the business is working toward.
What You’ll Do
Maintain and improve the Quality Management System in compliance with ISO 13485 and FDA Quality System Regulation.
Lead Management Review and internal audit programs.
Oversee document control, change control, and training systems.
Ensure regulatory compliance and inspection readiness.
Serve as the primary quality contact for regulatory bodies, including the FDA.
Lead responses to regulatory inspections and customer audits.
Oversee nonconformance management, CAPA, complaint handling, and product release and acceptance activities.
Ensure robust validation programs for equipment, processes, and software.
Lead and develop the Quality organization across multiple sites.
Build the QMS and help create the quality culture the company is building.
Provide training and guidance to cross-functional teams including engineering, manufacturing, and supply chain.
Help build the team and create a succession plan for the future.
Who You Are You are a quality leader with strong medical device experience who can step into a business that is rebuilding and provide both structure and mentorship. You understand quality systems, regulatory expectations, and compliance documentation, but you also know how to develop people and help shape culture. This role requires someone who can assess weaknesses, make the right moves, and build a stronger quality organization over time.
Preferred Experience & Attributes
Bachelor’s degree required, Master’s degree preferred.
Degree in Engineering, Life Sciences, or related field preferred.
10–15+ years in medical device quality.
5–10+ years in quality leadership.
Strong experience with ISO 13485.
Strong experience with 21 CFR Part 820.
Strong experience with QMS and CAPA.
Experience in medical device manufacturing environments.
Strong regulatory and compliance documentation experience.
Experience in a restructuring environment.
ASQ Certified Quality Engineer (CQE) preferred.
ASQ Certified Quality Manager (CMQ/OE) preferred.
Six Sigma Black Belt preferred.
Why This Role Matters The company’s quality system has been in place for decades and needs to be upgraded. The registrar has identified gaps, and the business believes the system needs to be brought to a higher level rather than rebuilt from scratch. This hire will play a central role in updating the QMS, building the right team, mentoring developing talent, and helping the business support higher-level quality work moving forward.
Reporting Structure
Reports to the Managing Director / President, Nolato Vermont.
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