Stryker Corporation

Senior Quality Engineer

Stryker Corporation$84K — $136K *
Cary, IL 60013In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science or engineering discipline
  • 2+ years of experience in engineering, quality, manufacturing, or operations in a regulated industry
  • Preferred experience in validation activities
  • Knowledge of pharmaceutical and/or medical device manufacturing processes
  • Familiarity with FDA regulations and ISO standards
  • ASQ Certified Quality Engineer or equivalent certification preferred

Responsibilities

  • Maintain KPIs to monitor process and product quality
  • Participate in and occasionally lead process improvement initiatives
  • Partner with Operations and Business functions to ensure quality performance
  • Collaborate with QA, cross-functional teams, and suppliers to address quality issues
  • Apply risk management principles to manufacturing operations
  • Support internal and external audits of quality systems
  • Lead medium-scope quality system projects

Benefits

  • Eligibility for bonuses
  • Comprehensive benefits package
  • Onsite work flexibility
  • Opportunities for professional development and training
  • Participation in process improvement initiatives
Full Job Description
Work Flexibility: Onsite

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%

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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