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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
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Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
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Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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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
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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.
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Investigate and drive complaint records to closure in a timely manner.
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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.
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Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
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Calculate Failure/Harm occurrence rankings based on field data as required.
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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.
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Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
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Support internal and external audits (FDA, ISO, MDSAP, etc.)
What you need
Basic Qualifications:
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Bachelor’s Degree in Engineering, Science or equivalent focus
Preferred Qualifications:
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Experience in a regulated industry (Medical, Aerospace, etc.)
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Experience and knowledge of failure investigation techniques and related tools: 8D, Root Cause Analysis, etc.
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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.
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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
