Product Quality Leader — Post-Market & Stability

Stryker; Cary (IL); On-site; USD 113,000 - 188,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan

Life and AD&D insurance

Short-term disability

Job summary

Stryker is seeking an Associate Manager, Product Quality to lead commercial quality activities across the product lifecycle for the Sage in Cary, IL site. The role ensures quality, safety, compliance, and performance of marketed products in pharmaceuticals, cosmetics, and medical devices.

Responsibilities include overseeing complaint handling, stability programs, PQRs, and data-driven improvements, while coordinating with Regulatory Affairs, Marketing, Sales, and Manufacturing.

Qualifications

• BA/BS in science, engineering, or related field.
• 6+ years in quality engineering or related commercial quality functions.
• Proven quality management and system improvements experience.
• Experience with product complaints, investigations, CAPAs, quality system processes, and quality monitoring activities.
• Experience overseeing or supporting pharmaceutical stability programs.
• Strong knowledge of cGMP, FDA regulations, ICH guidelines, product complaint management, stability programs, and CAPA systems.

Responsibilities

• Oversee and continuously improve product quality activities across lifecycle and ensure regulatory compliance.
• Lead commercial product quality activities and coordinate cross-functional teams.
• Ensure complaints are evaluated, investigated, trended, and closed per regulations and procedures.
• Improve the stability program design, execution, and data review to comply with global requirements.
• Coordinate and support product quality reviews and other monitoring activities to assess performance.
• Analyze data to identify risks and opportunities for continuous improvement.
• Develop KPIs, dashboards, and reports for effective quality oversight.

Skills

Quality engineering

Leadership

Cross-functional collaboration

Regulatory knowledge

CAPA systems

Data analysis

Education

BA/BS in science or engineering

Tools

Quality Management Systems

Job description

Stryker is seeking an Associate Manager, Product Quality to lead commercial quality activities across the product lifecycle for the Sage in Cary, IL site. The role ensures quality, safety, compliance, and performance of marketed products in pharmaceuticals, cosmetics, and medical devices.

Responsibilities include overseeing complaint handling, stability programs, PQRs, and data-driven improvements, while coordinating with Regulatory Affairs, Marketing, Sales, and Manufacturing.