Associate Manager, Product Quality

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 support our Medical division at Sage in Cary, IL. This role provides leadership for commercial product quality activities across the product lifecycle, ensuring the continued quality, safety, compliance, and performance of marketed pharmaceutical, cosmetic and medical device products.

What You Will Do

• Provide oversight and continuous improvement of product complaint handling, stability program, product quality reviews, and product health risk assessments. Ensure product quality monitoring activities are performed in compliance with applicable US and International regulations. Passionately drives team to execute initiatives and projects to enhance product quality performance for our customers.
• Lead commercial product quality activities, including product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Ensure product complaints are appropriately evaluated, investigated, trended, escalated, and closed in accordance with regulatory requirements and internal procedures.
• Lead and continuously improve the stability program, including study design, execution, monitoring, reporting, and data review activities, while ensuring compliance with ICH, FDA, and global regulatory requirements.
• Coordinate and support product quality reviews (PQRs) and other product quality monitoring activities to assess product performance and maintain a state of control.
• Analyze and trend complaint, stability, investigation, and product quality data to identify emerging risks, recurring issues, and opportunities for continuous improvement.
• Ensure compliance with corporate policies and procedures regarding product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Develop and maintain quality metrics, e.g., Key Process Indicators (KPIs), dashboards, and management reports that support effective product quality oversight and data-driven decision making.
• Support in regulatory and internal audits on matters relating to product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Influence cross-functional teams; such as Regulatory Affairs, Marketing, Sales, Manufacturing, R&D, Supply Chain, and Quality teams, to address product quality related inquiries.
• Identify and implement corrective actions to ensure the continued quality, safety, and performance of marketed pharmaceutical, cosmetic and medical device products
• Build, lead, and develop a high-performing team by setting clear goals and performance expectations, coaching and addressing performance, while recruiting, onboarding, and retaining top talent to foster a culture of accountability, collaboration, continuous improvement, and strong business results.

What you need

• Bachelor of Arts (BA) or Bachelor of Science (BS) in a science, engineering, or related discipline is required.
• Minimum of 6+ years of experience in quality engineering, stability programs, quality assurance, product quality, post-market quality, quality systems, or related commercial quality functions in a regulated environment is required.
• Proven experience in quality management and system improvements.
• Experience managing or supporting product complaints, investigations, CAPAs, quality system processes, and quality monitoring activities.
• Experience overseeing or supporting pharmaceutical stability programs.
• Strong understanding of:
• cGMP requirements
• FDA regulations
• ICH guidelines
• Product complaint management
• Stability programs
• CAPA systems

Preferred

• Minimum of 3+ years of supervisory experience with demonstrated people‑leadership exposure, including mentoring, training, and developing high‑performing direct and indirect reports
• Master of Arts (MA), Master of Science (MS), Certified Quality Engineer (CQE), or Certified Reliability Engineer (CRE) preferred.

$112,900 - $188,100 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.