Senior Customer Quality Engineer

Stryker is seeking a Senior Customer Quality Engineer to join our team in Redmond, WA. This hybrid role supports continuous improvement efforts and ensures the highest level of product and process quality in post-market environments. You'll be responsible for leading investigations into customer complaints, nonconformances (NCs), and corrective and preventive actions (CAPAs), Product Field Action Assessments (PFAAs), driving resolution, and ensuring compliance.

This is an excellent opportunity for a results-driven professional who thrives in a fast-paced, highly regulated environment. The ideal candidate will be action-oriented, able to manage complexity, communicate effectively across functions, and learn quickly.

Work Flexibility:

Hybrid : Candidates must reside within a commutable distance to Redmond, WA, and be able to work onsite several times per week.

What you will do:

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  Analyze and report post-market data (e.g., complaints, service reports, MDR/MIRs, Q-metrics) to identify trends and areas for improvement

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  Lead and support complaint investigations, ensuring timely and thorough resolution

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  Own and/or contribute to NC and CAPA investigations and records

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  Support Change Orders (CO) and participate in design review processes

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  Conduct and update risk analyses, including development of risk management documentation

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  Calculate failure and harm occurrence ratings using field data

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  Provide input on design feedback related to safety, durability, and reliability during design reviews and risk assessments

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  Ensure compliance with internal quality procedures and regulatory requirements, including FDA Quality System Regulations (QSR's)

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  Support product field actions (PFAs), including investigation and documentation (e.g., HHEs, presentations)

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What you need:

Basic Qualifications:

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  Bachelor's degree in Engineering, Science, or related discipline

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  2+ years of Quality Engineering experience

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Preferred Qualifications:

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  Experience in a regulated industry (e.g., Medical Device, Aerospace)

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  Knowledge of investigation methodologies (e.g., 8D, Root Cause Analysis)

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  Ownership and lead investigator for NC, CAPA, and Product Field Action Assessment

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  Demonstrated leader and mentor to colleagues

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  Familiarity with statistical analysis tools and techniques

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  Understanding of ISO 13485, ISO 14971, and quality system regulations

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  Experience developing or implementing design and process controls

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  $88,800- $142,300salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.? Individual pay is based on skills, experience, and other relevant factors.

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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.

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.