Senior Engineer, Advanced Quality

Stryker•Portage, MI

1d•Hybrid

About The Position

This role focuses on leading quality engineering activities within new product development projects for medical devices. The position supports the integration of quality processes, risk management, and regulatory requirements throughout the design and manufacturing lifecycle. The Senior Engineer will work cross-functionally to ensure product and process quality meet internal standards and external regulations. This is a hybrid role, requiring candidates to reside within commuting distance of Portage, MI, and be able to work onsite several days per week.

Requirements

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.)

Nice To Haves

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)

Responsibilities

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
Collaborate 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