Senior Customer Quality Engineer

Redmond - USA

Monthly Salary: $ 88800 - 142300

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

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. Youll 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:

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
2 years of Quality Engineering experience

Preferred Qualifications:

Experience in a regulated industry (e.g. Medical Device Aerospace)
Knowledge of investigation methodologies (e.g. 8D Root Cause Analysis)
Ownership and lead investigator for NC CAPA and Product Field Action Assessment
Demonstrated leader and mentor to colleagues
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

$88800 - $142300 salary 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.

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.

Required Experience:

Senior IC

Work Flexibility: HybridStryker 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. Youll be responsible for leading investigat...

Work Flexibility: Hybrid

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
2 years of Quality Engineering experience

Preferred Qualifications:

Experience in a regulated industry (e.g. Medical Device Aerospace)
Knowledge of investigation methodologies (e.g. 8D Root Cause Analysis)
Ownership and lead investigator for NC CAPA and Product Field Action Assessment
Demonstrated leader and mentor to colleagues
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

$88800 - $142300 salary 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.

Travel Percentage: 10%

Required Experience:

Senior IC

Key Skills

Debugging
Remote Access Software
IT Service Management
IOS
Multithreading
VPN
Neo4j
FISMA
SSO
Github
Google Suite
Troubleshooting

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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