Stryker Corporation

Staff Engineer Quality Process

Stryker Corporation • $89K — $148K *
Chandler, AZ 85225In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering or related field
  • 5+ years of relevant experience
  • Experience in the medical industry
  • Knowledge of US and International Medical Device Regulations
  • Familiarity with ISO 13485, GDP, GMP
  • Strong communication and project management skills
  • Ability to manage multiple tasks simultaneously

Responsibilities

  • Collaborate with operations to ensure quality performance
  • Address quality issues with customers and cross-functional teams
  • Mentor teams and oversee NC/CAPA processes
  • Lead development and improvement of manufacturing processes
  • Conduct investigations during concession management
  • Review change management activities and ensure robustness
  • Interpret KPI trends to drive continuous improvement

Benefits

  • Work onsite in Chandler, Arizona
  • Mentorship opportunities within a cross-functional team
  • Engagement in high-level problem-solving initiatives
  • Involvement with internal and external audits
  • Opportunity for travel as needed to support initiatives
Full Job Description
Work Flexibility: Onsite

The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona.

What you will do
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
  • Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
  • Initiates and leads in the development and improvement of the manufacturing processes for existing products.
  • Oversight and leads investigations during concession management.
  • Review and approval of change management activities, challenges effectiveness and drives strong review.
  • Interpret KPI trends, drive continuous improvement process.
  • Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
  • Subject matter expert in risk management practices and concepts.
  • Develop and provide input by identifying opportunities and weaknesses.
  • Proficiency in and provides technical direction in optimization of inspection methods and sampling.
  • High proficiency in statistical methods and application.
  • Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.
  • May manage audit logistics and/or preparation.
  • Aids in the development of validation strategies for existing products.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
  • Coach and mentor others in quality topics and activities.
  • Some travel may be required.


What you need
  • Bachelor of Science in engineering or related discipline.
  • Minimum of 5+ years' experience.
  • Previous medical industry experience required.
  • Understanding of US and International Medical Device Regulations.
  • Pervious product transfer experience required.
  • Familiarity with ISO 13485, GDP, GMP required.
  • Strong knowledge of Quality Concepts ( e.g. Risk Management, CAPA, Audits, Statistics).
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.


Preferred
  • MS, CQE, or CRE.
  • Six Sigma Green or Black belt.
  • Experience in launching new production lines desired.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired.
  • Ability to represent Quality function within and across project teams.
  • Strong interpersonal skills, written, oral communication and negotiations skills.
  • Strong in critical thinking and "outside the box" thinking.
  • Highly developed problem-solving skills.
  • Strong analytical skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently and as part of cross-functional teams.
  • Experience in working in a compliance risk situation.


United States of America Pay Ranges:
  • USN: $89,300 - $148,800 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Stryker Corporation.

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
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Stryker Corporation

More Pharmaceuticals & Biotech Jobs

Find similar Staff Engineer Quality Process jobs:

NationwideChandler, AZ