Quality Management Systems (QMS) Manager
Quality Management Systems (QMS) Manager
About the Opportunity
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.
Key Responsibilities
- 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.
Qualifications
Required
- 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.
Preferred
- 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.
What We're Looking For
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.
If you're interested in learning more about this confidential opportunity, please apply for additional details.
FAQs
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