Staff Post-Market Quality Engineer (Hybrid)

Staff Post-Market Quality Engineer - Hybrid

Stryker is hiring a Staff Post-Market Quality Engineer, also known as a Staff Customer Quality Engineer, in Redmond, WA. In this role, 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, also support field action related activities i.e. investigations, HHEs, presentations, etc.
• 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
• 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 reports, 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 internal and external audits (FDA, ISO, MDSAP, etc.)

What you need

Basic Qualifications:

• Bachelor’s Degree in Engineering, Science or equivalent focus
• 4+ 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.
• 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.

$98,300.00 - $161,100.00 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