Quality Director - Med Device QMS Transformation Lead

Guided Search Partners; Town of Vermont (WI); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading executive search firm is partnering with a medical device manufacturer in Wisconsin to find a Quality Director. This role involves maintaining and improving the Quality Management System, mentoring a team, and ensuring compliance with regulations. The ideal candidate should have 10–15 years of experience in medical device quality and strong leadership skills. This crucial position helps elevate the company's quality systems and supports future growth. Competitive compensation and significant impact in rebuilding a culture are part of this opportunity.

Qualifications

• 10–15+ years in medical device quality required.
• 5–10+ years in quality leadership required.
• Experience in medical device manufacturing environments.

Responsibilities

• Maintain Quality Management System in compliance with ISO 13485.
• Lead Management Review and internal audits.
• Serve as the primary quality contact for regulatory bodies.

Skills

Quality management systems

Regulatory compliance

Team development

ISO 13485

CAPA experience

Education

Bachelor’s degree

Master’s degree (preferred)

Degree in Engineering or Life Sciences

Job description

A leading executive search firm is partnering with a medical device manufacturer in Wisconsin to find a Quality Director. This role involves maintaining and improving the Quality Management System, mentoring a team, and ensuring compliance with regulations. The ideal candidate should have 10–15 years of experience in medical device quality and strong leadership skills. This crucial position helps elevate the company's quality systems and supports future growth. Competitive compensation and significant impact in rebuilding a culture are part of this opportunity.