Sr. Quality Management System Specialist

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

Job summary

Stryker in Portage, Michigan is seeking a Senior Quality Management System Specialist. Hybrid work arrangement supported, focused on designing, maintaining, and improving a global QMS to enable regulatory approvals and business growth. You will collaborate across functions and contribute to audits, training, and continuous improvement.

The role requires a bachelor’s degree and 3+ years in a regulated environment, with preference for knowledge of medical device regulations and change control.

Qualifications

• Bachelor’s degree in science, engineering, business or related field.
• 3+ years in a regulated industry environment.
• Knowledge of medical device regulations is preferred.

Responsibilities

• Support and maintain a compliant Quality Management System aligned with global medical device regulations.
• Develop and update quality system processes, procedures, and documentation.
• Assess and quantify quality system requirements to optimize structure and scalability.
• Identify and implement continuous improvement opportunities for quality processes.
• Support governance activities with data-driven inputs.
• Partner with stakeholders to reflect operational activities in quality processes.
• Prepare for internal, external, and third-party quality system audits and follow-up actions.
• Contribute to quality system training content and delivery.

Skills

Quality management

Regulated industry experience

Cross-functional collaboration

Audits support

Education

Bachelor's degree in science/engineering/business

Tools

Quality systems change control

Audit management systems

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.