Stryker Corporation

Associate Manager, Product Quality

Stryker Corporation$112K — $188K *
Cary, IL 60013In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or related field required.
  • 6+ years in quality engineering or related commercial quality functions in a regulated environment required.
  • Experience in quality management and system improvements is essential.
  • Proven track record managing product complaints and CAPAs.
  • Experience with pharmaceutical stability programs is critical.
  • Strong knowledge of cGMP, FDA regulations, ICH guidelines, and quality systems.

Responsibilities

  • Oversee and improve product complaint handling and quality initiatives.
  • Lead commercial product quality activities and stability programs.
  • Ensure compliance in evaluating and escalating product complaints.
  • Continuously improve stability programs through effective study design and execution.
  • Analyze product quality data to identify risks and improvement opportunities.
  • Coordinate product quality reviews to assess and maintain product performance.
  • Support audits related to product management and quality assessments.

Benefits

  • Work flexibility with hybrid or onsite options available.
  • Opportunity to build and lead a high-performing team.
  • Engagement in cross-functional collaboration with various departments.
  • Impact on enhancing product quality performance for customers.
Full Job Description
Work Flexibility: Hybrid or Onsite

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

Required
  • 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

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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