Senior Customer Quality Engineer (Hybrid)

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:

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

Senior Customer Quality Engineer (Hybrid)

Stryker is hiring a Senior Customer Quality Engineer in Redmond, WAAs a Senior Customer Quality Engineer, you will be responsible for continuous product and process quality improvements. You will conduct investigations into Customer Complaints, NCs, and CAPAs stemming from the products in the field. You will support root cause activities and identify potential failure modes, risks, and resolve customer issues appropriately.

Work Flexibility: Hybrid.

The candidate must reside within a commutable distance to Redmond, WA and is expected to be onsite at the facility multiple times/week.

we want

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• 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. 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

• Gather, analyze, and provide post-market data (e.g. Q-metric, service reports, complaints, MDR/MDV, trending) to the organization and identify opportunities for quality improvements.
• Investigate and drive complaint records to closure in a timely manner.
• Communicate with Customers, members of Field Service, and Sales organizations to gather information necessary to carry out investigations and document accurately and thoroughly NC and CAPA investigations.
• Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
• Calculate Failure/Harm occurrence rankings based on field data as required.
• Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality reports, design reviews, risk analyses, and customer research.
• Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and update as necessary.
• Support internal and external audits (FDA, ISO, MDSAP, etc.)

What you need

Basic Qualifications:

• Bachelor's Degree in Engineering, Science or equivalent focus
• 2+ years of relevant work experience

Preferred Qualifications:

• Experience in a regulated industry (Medical, Aerospace, etc.)
• Experience and knowledge of failure investigation techniques and related tools: 8D, Root Cause Analysis, etc.
• The following experiences/skill sets are highly desirable: ISO 13485 and ISO 14971 Industrial statistical techniques. Development and implementation of design and process controls.

$86,600.00- $138,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors
About Stryker

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 a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, 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.

Know someone at Stryker?
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.