Staff Quality Engineer Jobs

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is hiring a Staff Quality Engineer in Salt Lake City, Utah, to support Neurovascular! As a Staff Engineer, you will participate with a cross-functional operations team to effectively deliver high-quality products and processes that contribute to Stryker’s highly effective quality system. You will provide quality leadership and direction in quality assurance, control, and preventive activities within operations and other business functions, with a focus on preventive measures and continuous improvement of products and processes.

In addition, you will advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Furthermore, you will work with internal customers and suppliers in support of supplier quality issues and provide technical support for activities related to supplier quality system assessment and performance evaluation.

Who we want

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

• Responsible for initiation, management and support of ship, product Holds, potential product escapes.
• Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
• Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
• Drive resolution of quality issues associated with assigned suppliers. Proactively ensure all supplier related material quality issues are effectively communicated to key stakeholders.
• Proficiency in technical understanding of manufacturing prints and tolerancing.
• Support global supplier audit team with key supplier site metrics. Negotiate sustaining quality agreements with suppliers.
• Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.
• High proficiency in statistical methods and application.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
• Ensure compliance to regulation and standards.
• Interpret KPI trends, take action as necessary, driving a continuous improvement process.
• Proficiency in and provides technical direction in optimization of inspection methods and sampling.
• Mentor the quality team and others business function in quality topics and activities, with several topics at expert level.
• Mentor and provide technical direction across multiple areas of expertise.
• May deputize proficiently for management in temporary absence, periodic review boards, business meetings etc. on a regular basis.
• Lead and resolve quality issues with suppliers and partner with internal customers.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Mentors, provides oversight and approval of NC & CAPA, activist and high-level expert in problem solving and root causing activities.
• Review and approval of change management activities, challenges change effectiveness and drives strong review.
• Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.

What you need

Required:

• 4+ years’ experience working in quality, manufacturing, engineering or in a highly regulated environment.
• Bachelor of Science in Engineering or related discipline

Preferred:

• Knowledge of Risk Based and statistical concepts
• Familiarity with ISO 13485, GDP, GMP concept
• Verification and Validation (V&V) strongly preferred
• Experience interacting with suppliers is a plus
• Ability to influence and work cross-functionally
• Have a good understanding of engineering and quality concepts/theories
• Strong foundation in quality systems

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com