Staff Quality Engineer, OEM/CM

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.