Senior Staff Quality Engineer

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

Stryker is hiring a Senior Staff Quality Engineer in Cary, IL! This Engineer will provide support and direction in quality assurance, control and preventative activities with a focus on sustaining products. Manages the execution and changes in quality activities for internal and external suppliers related to process development, verification, validation and manufacturing transfer while ensuring compliance to regulations and standards. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards. 

Who we want-

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do:

• Maintains KPIs for monitoring of process and/or product quality, performs analysis, and interprets trends. Proactively lead process improvements.
• Works closely with operations and the business functions to ensure quality performance of product and processes. 
• Collaborates with Divisional QA, cross-functional, shared services and supplier’s teams to address top quality issues. 
• Participate in the development of basic systems by translating manufacturing and quality requirements into robust processes
• Mentor others on strategic risk management principles for decision making and processes (manufacturing, QMS) across functions and sites, and participate in related activities.
• Leads internal and external audits by regulatory agencies, notified bodies, competent authorities, etc with subject matter expertise.
• Leads quality system projects of a high scope and complexity.
• Participates in the development and review of process and equipment validation/qualification and MSAs.
• Lead and apply principles of continuous improvement to events of increasing complexity or novel technologies. Coach and mentor others on principle application.
• Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. 
• Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes.
• Can coach & mentor others on technical writing principles.
• Mentor and Influence others in root cause/problem solving efforts, including advanced troubleshooting and events of increasing complexity.

What you’ll need: 

Required:

• Bachelors Degree in a Science or Engineering discipline
• Minimum of 6+ years of working experience in engineering, quality, manufacturing, pharmaceuticals or regulatory environments.
• Solid foundation in validation principles

Preferred:

• Automation background preferred
• ASQ Certified Quality Engineer or similar certification preferred
• Proficient understanding of Pharmaceutical / Medical Device manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, ICH Q7/Q10
• Lean Six Sigma/Investigation (CAPA) training
• High level knowledge/experience of risk based and statistical techniques; process risk, statistical sampling plans, process capability, and Gage R&Rs

Our benefits:

• 12 paid holidays annually

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.