Senior Manager, QMS
Senior Manager, QMS
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Job Description
We are seeking a Senior Manager QMS in Portage Michigan to lead the Global Quality Operations (GQO) function for our Medical Division! You will drive strategic compliance and business objectives within the Quality Management System (QMS) while supporting the Franchise Quality Leader (FQL) and Divisional Manufacturing Leader (DML).
You will lead teams focused on Nonconformance (NC) Corrective and Preventive Actions (CAPA) and QMS activities ensuring consistent compliant and efficient operations. Additionally you will collaborate cross-functionally to uphold product quality and ensure alignment with industry standards and regulatory requirements.
What You Will Do:
Leadership:
Fosters a positive inclusive team culture through open communication engagement and development.
Sets strategic direction for Quality Systems teams to deliver strong service and business support.
Drives talent strategy and collaboration; builds trust and develops team capabilities across the franchise.
Regulatory Compliance & Auditing:
Coordinate and manage external audits and ensure timely responses to audit findings.
Maintains an up-to-date Quality Management System aligned with evolving regulations standards and policies.
NC and CAPA Management:
Oversee NC and CAPA systems to ensure timely containment thorough investigations and effective corrective actions.
Utilizes data analysis to identify adverse trends and ensures root cause analysis and effectiveness checks are completed.
Training & Development:
Develops and delivers strategic training on quality systems regulations and QMS processes across all levels.
Mentors and develops the Quality team to build capability and performance.
Promotes a strong quality culture through ongoing education and communication.
Continuous Improvement:
Drives continuous improvement and harmonization of Quality Systems across GQO focusing on standardizing work and optimizing resources for efficiency.
Designs and coordinates governance structures and communication platforms for QS strategic initiatives.
Develop strategic roadmaps for key QS functions including NC/CAPA Change Control Document Control and QMS
Cross-functional Collaboration:
Influence across the organization by building effective relationships with key stakeholders across divisional functions QS QA Corporate NPI and M&A to drive collaboration.
Partners with Franchise Quality Leader and divisional QMS leaders to develop and deploy Quality Systems strategy.
What You Need:
Required
Bachelors degree required. Preferred to be in engineering sciences or related fields.
10 years of experience in quality assurance quality systems management or closely related.
Experience in a regulated industry.
3 years in a leadership role overseeing quality systems and NC/CAPA.
Preferred:
In-depth knowledge of regulatory standards including ISO 13485 FDA 21 CFR Part 820 ISO 14971 and EU MDR.
Proven experience in leading audits (internal external regulatory).
Excellent analytical and problem-solving skills with a strong focus on data-driven decision-making.
Familiarity with quality management software (e.g. onePLM TrackWise etc.).
Required Experience:
Senior Manager
Employment Type
Full-Time
