Associate Quality Manager, Stability

Stryker is seeking an Associate Quality Manager, Stability to support our Stryker Sage Medical division in Cary, IL to provide leadership for the Stability function, overseeing team performance, processes, and procedures while advancing quality excellence across the product lifecycle. This role ensures compliance with U.S. and international regulatory requirements and supports quality activities from product development through commercial manufacturing and post‑market surveillance.

What you will do:

• Lead and continuously advance a best‑in‑class Stability program, ensuring compliance with global regulatory requirements (ICH, FDA, ISO) and inspection readiness at all times

• Provide strategic and operational oversight of stability study design, execution, monitoring, and reporting, including support for regulatory submissions and product quality reviews

• Establish, maintain, and improve stability policies, procedures, systems, and documentation to drive consistency, scalability, and data integrity

• Analyze stability data and trends to proactively identify risks, mitigate issues, and drive continuous quality and product lifecycle improvements

• Plan, prioritize, and oversee team deliverables; monitor progress and assess results to ensure alignment with organizational and business objectives

• Partner cross‑functionally with Quality, Regulatory, R&D, Manufacturing, and Supply Chain to ensure alignment, effective decision‑making, and timely outcomes

• Build and lead high‑performing teams by setting clear goals, KPIs, and performance expectations; coach, develop, and address performance to maximize engagement and results

• Recruit, onboard, and retain top talent while fostering a culture of accountability, collaboration, and continuous improvement

What you need:

Required

• Bachelor’s degree in a Science, Engineering, or related

• Minimum of 6+ years’ experience - supporting Pharmaceutical Quality Control and Quality Assurance functions, with demonstrated success driving quality improvements through data and quality system improvements.

• Deep expertise in pharmaceutical stability testing aligned with ICH and global regulatory standards, supported by comprehensive knowledge of diverse analytical techniques and instrumentation.

• Proven ability to analyze complex data sets using sound mathematical and statistical principles to inform decisions and drive effective, executable actions

Preferred

• 3+ supervisory experience with demonstrated people‑leadership exposure, including mentoring, training, and developing high‑performing direct and indirect reports

• Quality Engineer (ASQ CQE) Certification preferred.

• Demonstrated ability to effectively communicate and influence stakeholders at all levels of the organization, with proven success working in cross‑functional team environments