Site QMS Leader

Site QMS Leader

As the Site Quality Management System (QMS) Leader, you'll play a critical role in shaping and strengthening the site's quality culture. You'll lead 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.

In this role, you'll monitor and evaluate QMS performance, identify opportunities for improvement, and partner with cross‑functional teams to implement sustainable solutions. You'll 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.

You'll 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. Your leadership will help ensure the site continues to deliver high‑quality products, meet customer expectations, and maintain a culture of excellence.

Please note that this role requires onsite presence five days per week, Monday through Friday.

• Lead the implementation, maintenance, and continuous improvement of the site's 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 Gen Suite, 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.

Required:

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

Preferred:

• Internal ISO
  9001 Auditor or other auditor experience.
• Lean Six Sigma experience.
• Experience providing training to all levels.
• SharePoint and Gensuite administration experience.

• Base Pay Range: $84,000 – $122,650
• Incentive or sales variable compensation payments based on the Company's plans.
• Health, dental & vision insurance, including critical illness coverage and optional orthodontia coverage.
• Paid parental leave for the birth of a child, adoption and surrogacy reimbursement.
• Short‑term disability with 100% base salary coverage.
• Company‑funded counseling (EAP) and assistance in finding care for children, parents, or pets.
• 25 days of Paid Time Off (PTO) plus paid holidays. Additional time off with years of service.
• 401(k) savings plan with 5% employer match plus additional contribution.