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Job description
Senior Engineer, Advanced Quality
Portage, MI
Join a role focused on leading quality engineering activities within new product development projects for medical devices. This position supports the integration of quality processes, risk management, and regulatory requirements throughout the design and manufacturing lifecycle. You will work cross-functionally to ensure product and process quality meet internal standards and external regulations.
Work Flexibility:
Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.
What You Will Do
- Lead quality activities for new product development projects, ensuring alignment with quality systems and regulatory requirements
- Develop and maintain quality documentation, including design history files, verification and validation reports, and risk management records
- Define and support verification and validation strategies, ensuring objective evidence meets acceptance criteria
- Conduct risk management activities, including developing risk plans, performing risk analysis, and verifying mitigation effectiveness
- Analyze quality data using statistical methods to establish acceptance criteria, process parameters, and resolve quality issues
- Collaborating with Engineering, Manufacturing, Regulatory, and Operations to support design reviews and product development milestones
- Develop and approve inspection plans, product drawings, and manufacturing documentation for new products
- Support product transfers to manufacturing and participate in audit readiness and regulatory interactions
What You Will Need
Required
- Bachelor’s degree in Engineering, Science, or related discipline
- Minimum 2 years of experience working in a regulated environment
- Experience applying quality principles such as CAPA, audit processes, and statistical analysis
- Experience supporting design control, risk management, and validation activities
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
Preferred
- Experience in medical device product development lifecycle
- Certification such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Green/Black Belt
- Experience applying advanced quality tools (e.g., FMEA, root cause analysis, mistake-proofing)
- $77,700 - $129,500 USD Annual
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. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.
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