Customer Quality Engineer

Work Flexibility: Hybrid

Stryker is hiring a Customer Quality Engineer in Redmond, WA. As a 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.

What you will do

• Gather, analyze, and present post-market data (E.g., Q-metric, service reports, complaints, MDR/MIR, trending) to the organization and identify opportunities for quality improvements
• Investigate and drive complaint records to closure in a timely manner
• Own/support NC and CAPA records and investigations
• Communicate with customers, members of Field Service, and the Sales organization to collaborate and ensure issues are resolved quickly and effectively
• Support Change Orders (CO) and the design review process
• Conduct/update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
• Calculate failure/harm occurrence rating based on field data
• 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 with Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
• Support product field action (PFA) related activities i.e. investigations, HHEs, presentations, etc.

What you need

Basic Qualifications:

• Bachelor’s Degree in Engineering, Science or equivalent focus
• 0+ years of 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.
• Familiarity with statistical analysis techniques
• The following experiences/skill sets are highly desirable: ISO 13485 and ISO 14971 Industrial statistical techniques. Development and implementation of design and process controls.

$77,500.00 - $120,500.00 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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.