Customer Quality Engineer
Customer Quality Engineer
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Job Description
Customer Quality Engineer (Hybrid)
Redmond WA
Stryker is seeking a 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. Youll be responsible for leading investigations into customer complaints nonconformances (NCs) and corrective and preventive actions (CAPAs) 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:
- Analyze and report post-market data (e.g. complaints service reports MDR/MIRs Q-metrics) to identify trends and areas for improvement
- Lead and support complaint investigations ensuring timely and thorough resolution
- Own and/or contribute to NC and CAPA investigations and records
- Support Change Orders (CO) and participate in design review processes
- Conduct and update risk analyses including development of risk management documentation
- Calculate failure and harm occurrence ratings using field data
- Provide input on design feedback related to safety durability and reliability during design reviews and risk assessments
- Ensure compliance with internal quality procedures and regulatory requirements including FDA Quality System Regulations (QSRs)
- Support product field actions (PFAs) including investigation and documentation (e.g. HHEs presentations)
What you need:
Basic Qualifications:
- Bachelors degree in Engineering Science or related discipline
- 0 years of relevant experience
Preferred Qualifications:
- Experience in a regulated industry (e.g. Medical Device Aerospace)
- Knowledge of investigation methodologies (e.g. 8D Root Cause Analysis)
- Familiarity with statistical analysis tools and techniques
- Understanding of ISO 13485 ISO 14971 and quality system regulations
- Experience developing or implementing design and process controls
$79500.00 - $123500.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on 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 contractors legal duty to furnish information.Employment Type
Full-Time
