Sr. Quality Management System Specialist

Stryker Corporation; Portage (MI); Hybrid; USD 73,000 - 121,000; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Quality Management System Specialist to design, maintain, and improve a global QMS. This hybrid role supports regulatory approvals, quality processes, and governance across functions, including audits, training, and supplier/customer quality agreements.

The ideal candidate has a Bachelor’s degree in a related field and 3+ years in a regulated environment with knowledge of medical device regulations and quality systems change control.

Qualifications

• Bachelor’s degree in science, engineering, business, or related discipline.
• 3+ years of experience in a regulated industry environment.
• Preferred knowledge of US and international medical device regulatory requirements.
• Experience supporting quality systems such as audits, management review, quality planning, and corrective action processes.
• Experience supporting regulated information systems or quality systems change control.
• Exposure to good manufacturing and distribution practices within a quality environment.

Responsibilities

• Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances.
• Develop and update quality system processes, procedures, and documentation to reflect business needs and regulatory expectations.
• Assess and quantify quality system requirements to optimize structure, integration, and scalability.
• Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes.
• Support management review, quality planning forums, and related governance activities with data-driven inputs.
• Partner with stakeholders to ensure quality processes reflect actual operational activities, including support for new product development.
• Prepare for and support internal, external, and third-party quality system audits, including responses and follow‑up actions.
• Contribute to quality system training content and delivery to ensure effective adoption across the organization.

Skills

Quality Management Systems

Regulatory compliance

Audits and CAPA

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering/business

Job description

Work Flexibility: Hybrid. The Senior Quality Management System Specialist will help design, maintain, and continuously improve a quality management system that supports regulatory approval and business growth across global markets. You’ll collaborate across functions to ensure quality processes are not only compliant, but practical, efficient, and future-ready. Activities include Quality System documentation, Internal Quality Agreements, Supplier Quality Agreements, and general QMS activities related to Mergers and Acquisitions. This role is Hybrid in Portage, Michigan.

What You Will Do

Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances.

Develop and update quality system processes, procedures, and documentation to reflect business needs and regulatory expectations.

Assess and quantify quality system requirements to optimize structure, integration, and scalability.

Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes.

Support management review, quality planning forums, and related governance activities with data-driven inputs.

Partner with stakeholders to ensure quality processes reflect actual operational activities, including support for new product development.

Prepare for and support internal, external, and third-party quality system audits, including responses and follow‑up actions.

Contribute to quality system training content and delivery to ensure effective adoption across the organization.

What You Will Need

Bachelor’s degree in science, engineering, business, or a related discipline.

3+ years of experience working in a regulated industry environment.

Preferred Knowledge of U.S. and international medical device regulatory requirements.

Experience supporting quality systems such as audits, management review, quality planning, and corrective action processes.

Experience supporting regulated information systems or quality systems change control.

Exposure to good manufacturing and distribution practices within a quality environment.

United States of America Pay Ranges: USN: $72,500 - $120,900 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.