Work Flexibility: Hybrid

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

Bachelor’s 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.).

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.