Site QMS Leader

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS), ensuring alignment with global quality standards and business objectives.
• Develop, maintain, and manage quality documentation, procedures, and controlled document systems.
• Ensure ongoing compliance with ISO 9001 and other applicable quality standards by maintaining objective evidence and supporting certification activities.
• Plan, facilitate, and lead QMS Management Reviews while establishing and tracking site quality objectives aligned with global goals.
• Develop and execute the site's internal audit program, coordinate third-party registrar audits, and support external customer and regulatory audits.
• Build and maintain a cross-functional internal auditor network while coaching teams through audit findings and corrective actions.
• Monitor, analyze, and report QMS performance metrics, trends, and opportunities for continuous improvement to site and regional leadership.
• Champion a customer-focused quality culture by driving process improvements and promoting quality excellence across the organization.
• Maintain and administer quality systems and applications, including GenSuite, Gensuite ATS, gLIMS, and LIMS, ensuring data integrity and effective workflow management.
• Oversee supplier quality processes and support quality-related workflows that ensure consistent product and process performance.
• Partner with cross-functional teams to align quality initiatives with strategic business priorities and operational excellence goals.

Qualifications

• 4 year degree, business or technical major preferred
• 5+ years experience in Manufacturing, Quality or related role
• Strong leadership record
• Able to lead in matrix environment
• Excellent written and verbal communication skills
• Presentation skills to all levels
• Proficient in Microsoft Office applications

Preferred Qualifications

• Internal ISO9001 Auditor or other auditor experience
• Lever Six Sigma experience
• Experience providing training to all levels
• SharePoint and Gensuite administration experience

Benefits

What We Offer
Base Pay Range: $84,000 - $122,650
The actual salary offered is determined by factors including but not limited to education, experience, skill sets, and geography.
Local geographic pay differentials may not be reflected in the above pay range and will be discussed with you by a member of the HR team when applicable.

About the Role

The Site Quality Management System (QMS) Leader plays a critical role in shaping and strengthening the site's quality culture. This role involves leading the implementation, maintenance, and continuous improvement of the site's Quality Management System, ensuring alignment with global standards while driving operational excellence across the facility. The leader will monitor and evaluate QMS performance, identify opportunities for improvement, and partner with cross-functional teams to implement sustainable solutions. They will support the global Quality organization by leading internal audits, analyzing quality trends, maintaining documentation and quality systems, promoting a customer-focused mindset, and driving continuous improvement initiatives. The leader will also serve as the site expert for ISO 9001, ensuring ongoing compliance with ISO 9001:2015 requirements while leading future quality system upgrades and new standard implementations. Their leadership will help ensure the site continues to deliver high-quality products, meet customer expectations, and maintain a culture of excellence.

Schedule

Onsite presence five days per week, Monday through Friday