Quality Management Systems (QMS) Manager

Quality Management Systems (QMS) Manager (PR/582827) Sheboygan, Wisconsin

Salary: USD
120000 - USD
140000 per annum

Our client is seeking an experienced Quality Management Systems (QMS) Manager to lead and continuously improve their site-wide Quality Management System. This individual will oversee a team of six professionals across Quality Systems and Document Control while ensuring compliance with industry regulations, customer requirements, and internal quality standards.

This is an excellent opportunity for a quality leader who enjoys building robust systems, driving compliance initiatives, and partnering cross-functionally with manufacturing, operations, regulatory, engineering, and supply chain teams.

• Lead, mentor, and develop a team of six employees within Quality Systems and Document Control.
• Own and maintain the site's Quality Management System (QMS), ensuring compliance with applicable regulatory and customer requirements.
• Drive continuous improvement initiatives related to quality processes, procedures, and system effectiveness.
• Oversee document control processes, including creation, review, approval, revision, training, and archival of controlled documents.
• Manage quality system elements including:
  • CAPA (Corrective and Preventive Actions)
  • Change Control
  • Deviations and Non-Conformances
  • Internal Audits
  • Management Review
  • Training Systems
  • Supplier Quality Documentation
• Support customer, regulatory, and third-party audits while ensuring audit readiness across the facility.
• Analyze quality system metrics and KPIs to identify trends, risks, and opportunities for improvement.
• Partner with manufacturing, operations, engineering, regulatory, and supply chain teams to ensure quality standards are integrated throughout the organization.
• Ensure quality procedures remain current with evolving regulatory requirements and industry best practices.
• Lead investigations and facilitate root cause analysis activities when quality issues arise.

• Bachelor's Degree required.
• Minimum 7+ years of experience in manufacturing quality systems
  .
• Minimum 3+ years of people management experience with demonstrated success leading teams.
• Experience working within one or more of the following industries:
  • Food Manufacturing
  • Food Packaging
  • Medical Device Manufacturing
  • Pharmaceutical Manufacturing
• Strong understanding of Quality Management Systems, document control, and quality compliance requirements.
• Experience leading internal and external audits.
• Proven ability to drive continuous improvement initiatives and influence cross-functional teams.

• Experience with electronic Quality Management Systems (eQMS).
• Working knowledge of FDA, GMP, ISO 9001, ISO 13485, or related quality standards.
• Certification such as ASQ CQE, CQA, or equivalent is a plus.

The ideal candidate is a hands-on quality leader who can balance strategic quality initiatives with day-to-day execution. They will possess strong leadership skills, excellent organizational abilities, and a passion for building and sustaining world-class quality systems within a regulated manufacturing environment.

Thank you for submitting your application.