Senior Quality Engineer

Stryker is hiring a Senior Quality Engineer in Cary, IL to support Sage! In this role, you will support quality assurance, control, and preventive activities for sustaining products. You will support quality processes for internal and external suppliers, focusing on process development, verification, validation, and manufacturing transfer, while ensuring compliance with applicable regulations and standards.

What You Will Do:

• Maintain KPIs to monitor process and product quality; perform analysis and interpret trends.

• Participates in and occasionally leads process improvement initiatives.

• Partner with Operations and Business functions to ensure product and process quality performance.

• Collaborate with Divisional QA, cross-functional teams, shared services, and suppliers to address key quality issues.

• Apply risk management principles to manufacturing operations.

• Support internal and external audits (regulatory agencies, notified bodies, competent authorities).

• Lead medium-scope quality system projects.

• Participate in the development and review of process/equipment validations, qualifications, and measurement system analyses (MSAs).

• Execute internal quality deliverables related to engineering changes, manufacturing transfers, and supplier-initiated changes.

• Initiates, contains, communicates, and supports Commercial Holds for potential product escapes.

• Independently creates and approves technical documentation.

• Lead basic root cause investigations, including CAPAs within area of responsibility.

What You Need:

Required:

• Bachelor’s degree in science or engineering discipline.

• 2+ years of experience in engineering, quality, manufacturing, or operations within a regulated industry.

Preferred:

• Experience in validation activities.

• Experience with nonconformance (NC) and corrective and preventive actions (CAPA).

• ASQ Certified Quality Engineer or equivalent certification preferred.

• Understanding of pharmaceutical and/or medical device manufacturing processes.

• Knowledge of applicable regulations and standards, including FDA CFR Parts 210, 211, and 820; ISO 13485; ICH Q7/Q10.

• Training in Lean Six Sigma and CAPA/investigation methodologies.

84,900 - 110,500 - 136,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.