Work Flexibility: Hybrid

Customer Quality Engineer (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.

Who 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
• Ownership of activities that lead to improvement in Stryker Emergency Care Quality metrics
• Investigate and drive complaint records to closure in a timely manner
• Support NC and CAPA process and NC and CAPA investigations
• 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
• Work with cross-functional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive resolution for internal issues/projects
• May support Engineering Change Orders (ECO) and Process Change Orders (PCO)
• Champion determination of “true” root cause by utilizing appropriate problem-solving tools
• 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 report, design reviews, risk analyses, and customer research.
• Develop statistical rationale for testing, when required, to address post-market issues
• Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
• Support field action related activities i.e. investigations, HHEs, presentations etc.
• Support internal and external audits (FDA, ISO, MDSAP etc.)

What you need

Basic Qualifications:

• Bachelor’s Degree in Engineering or related field discipline

Preferred Qualifications:

• Experience in a regulated industry (Medical, Aerospace, etc.)
• Experience and knowledge of failure investigation techniques and related tools: 8D, 6 Sigma, Root Cause Analysis
• The following experiences/skill sets are highly desirable: ISO 13485 and ISO 14971 Industrial statistical techniques. Development and implementation of design and process controls.

• $75,200 - $117,000 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.