Senior Quality Engineer

Work Flexibility: Onsite

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.

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.