The Role
The Quality Management System Specialist will design and improve a quality management system that meets regulatory standards, supports audits, and collaborates with stakeholders.
Summary Generated by Built In
Work Flexibility: HybridTravel 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.
Quality Management System Specialist
Portage - MI
In this role, you 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.
Work Flexibility
Hybrid – must reside within a commutable distance to Portage, MI and work onsite several times per week.
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
Required
- Bachelor’s degree in science, engineering, business, or a related discipline.
- 0+ 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.
Top Skills
International Medical Device Regulatory Requirements
Quality Management Systems
U.S. Medical Device Regulatory Requirements
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
