Quality Engineer, OEM​/CM

Staff Quality Engineer, OEM/CM page is loaded## Staff Quality Engineer, OEM/CM locations:
Portage, Michigan time type:
Full time posted on:
Posted 2 Days Agojob requisition :
R558710

Work Flexibility:
Hybrid
** Staff Quality Engineer, OEM/CM
*** Portage, MI
* Join a team that ensures patients receive safe, reliable, high‑quality products through excellence in supplier quality. In this role, you will strengthen Stryker’s external supply chain by driving supplier performance, improving manufacturing capability, and supporting continuous improvement across OEM/CM partners. This is an exciting opportunity to influence product quality at scale and partner across global teams to deliver meaningful impact.
** Work Flexibility:
** Hybrid - must reside within a commutable distance to Portage, MI and work onsite several times per week.
** What You Will Do**
* ** Lead
* * quality issue resolution with OEM/CM partners, ensuring timely containment, corrective actions, and clear communication to internal stakeholders.
* ** Evaluate
* * supplier performance through KPIs, data analysis, and monthly reviews to ensure ongoing compliance with quality, service, and cost expectations.
* ** Participate
* * in external and internal audits, supporting regulatory compliance with GMP and global medical device requirements.
* ** Maintain
* * accuracy and integrity of supplier quality data, including Approved Supplier List updates and OEM/CM documentation.
* ** Collaborate
* * with sourcing, manufacturing, and quality teams to assess and address material quality issues and supplier changes.
* ** Support
* * Material Review Board processes, ensuring efficient assessment and disposition of non‑conforming materials.
* ** Drive
* * continuous improvement initiatives with OEM/CMs to enhance process capability, reduce defects, and strengthen supply chain performance.
* ** Contribute
* * to supplier audit planning, execution, and closure, ensuring alignment with regulatory and corporate quality system expectations.
** What You Will Need
**** Required Qualifications
*** Bachelor’s degree in Engineering or Science field, or equivalent technical discipline.
* 4+ years of experience in a manufacturing environment or equivalent.
* Knowledge of GMP, ISO 13485, and 21 CFR Part 820 standards.
* Knowledge of FMEA, validation programs, and statistical process control within a regulated environment.
** Preferred Qualifications
*** Internal Quality Auditor qualification (AS9100, ISO 13485, CFR 820, or comparable standards).
* Training or experience with continuous improvement methodologies.

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.
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