Stryker Corporation

Staff Advanced Quality Engineer

Stryker Corporation$89K — $148K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field
  • Minimum 4 years experience in Quality Engineering or Technical Engineering roles
  • Experience in regulated industry quality activities
  • Involvement in product development and new product introduction

Responsibilities

  • Lead quality engineering for new product development
  • Guide teams through design controls and risk management
  • Conduct and maintain risk management activities
  • Lead human factors engineering for user-focused products
  • Plan and execute design validation activities
  • Support process validation and establish quality controls
  • Develop inspection methods for compliance with product specifications
  • Review technical documents and conduct root cause analysis

Benefits

  • Hybrid work flexibility with onsite requirements
  • Opportunity to provide quality leadership across product lifecycle
  • Engagement with cross-functional teams in a dynamic environment
  • Focus on user-centered product development
  • Professional development opportunities in quality engineering certifications
Full Job Description
Work Flexibility: Hybrid

Staff Advanced Quality Engineer

Portage, MI

Join a team focused on advancing quality throughout the product development lifecycle in a regulated medical device environment. As a Staff Advanced Quality Engineer, you will collaborate with engineering, manufacturing, and project teams to ensure products meet quality, regulatory, and user requirements from concept through commercialization. This role offers the opportunity to provide quality leadership across new product development, design validation, risk management, and product launch activities.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.

What You Will Do
  • Lead quality engineering activities for new product development programs, ensuring compliance with applicable quality system and regulatory requirements.
  • Guide development teams through design controls, risk management, verification, validation, and product launch processes.
  • Conduct and maintain risk management activities, including risk assessments, risk analyses, and implementation of mitigation strategies throughout product development.
  • Lead human factors engineering activities to support the development of safe, intuitive, and user-focused products.
  • Plan, execute, and approve design validation activities to verify products meet defined user needs and intended use requirements.
  • Support process validation activities and establish quality controls that enable consistent manufacturing performance and long-term product quality.
  • Develop inspection methods and procedures for incoming materials, in-process controls, and finished products to ensure compliance with product specifications.
  • Review technical deliverables, investigate nonconformances and corrective actions, perform root cause analysis, and provide quality representation during cross-functional project reviews.


What You Will Need

Required Qualifications
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
  • Minimum 4 years of experience in a Quality Engineering or Technical Engineering role within a research and development or manufacturing environment.
  • Experience supporting quality activities within a regulated industry environment.
  • Experience supporting product development, design quality, design controls, or new product introduction activities.

Preferred Qualifications
  • Working knowledge of ISO 13485, ISO14971, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
  • Minimum 3 years of experience as an Advanced Quality Engineer, Design Quality Engineer, or equivalent role.
  • Experience in the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industry.
  • ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), GD&T certification, or equivalent professional certification.


$89,300 - $148,800 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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