As a Post-Market Quality Engineer you will play a critical role in strengthening product reliability across the lifecycle from post-market insights to product improvements that shape future innovations. This role offers meaningful impact cross-functional collaboration and the opportunity to influence products used by healthcare professionals worldwide.
Work Flexibility: Hybrid: candidates must reside within commuting distance of Portage MI and be able to work onsite several days per week.
What You Will Do
Investigate product failures by reviewing design history manufacturing records and field performance data to identify root causes and improvement opportunities.
Analyze and trend post-market product complaint data delivering regular data-driven insights to divisional quality leadership.
Update risk management documentation to reflect post-market findings and product changes ensuring continued product safety and effectiveness.
Participate in cross-functional product improvement teams to define prioritize and execute corrective and preventive actions.
Initiate track and document commercial product holds ensuring timely resolution and accurate records.
Support business units and commercial teams by providing post-market quality expertise and technical guidance.
Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards.
Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards including reviewing change documentation for technical robustness.
What You Will Need
Required Qualifications
Bachelors degree in engineering or related technical discipline.
Preferred Qualifications
Experience in quality engineering post-market quality regulatory compliance or a related field.
Experience working with regulatory authorities such as the U.S. Food and Drug Administration.
Experience conducting risk analysis and root cause investigations.
Experience performing and interpreting statistical data analysis.
$69500 - $110900 USD Annual
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:
IC
Work Flexibility: HybridPost-Market Quality EngineerPortage MIAs a Post-Market Quality Engineer you will play a critical role in strengthening product reliability across the lifecycle from post-market insights to product improvements that shape future innovations. This role offers meaningful impact ...
Work Flexibility: Hybrid
Post-Market Quality Engineer
Portage MI
As a Post-Market Quality Engineer you will play a critical role in strengthening product reliability across the lifecycle from post-market insights to product improvements that shape future innovations. This role offers meaningful impact cross-functional collaboration and the opportunity to influence products used by healthcare professionals worldwide.
Work Flexibility: Hybrid: candidates must reside within commuting distance of Portage MI and be able to work onsite several days per week.
What You Will Do
Investigate product failures by reviewing design history manufacturing records and field performance data to identify root causes and improvement opportunities.
Analyze and trend post-market product complaint data delivering regular data-driven insights to divisional quality leadership.
Update risk management documentation to reflect post-market findings and product changes ensuring continued product safety and effectiveness.
Participate in cross-functional product improvement teams to define prioritize and execute corrective and preventive actions.
Initiate track and document commercial product holds ensuring timely resolution and accurate records.
Support business units and commercial teams by providing post-market quality expertise and technical guidance.
Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards.
Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards including reviewing change documentation for technical robustness.
What You Will Need
Required Qualifications
Bachelors degree in engineering or related technical discipline.
Preferred Qualifications
Experience in quality engineering post-market quality regulatory compliance or a related field.
Experience working with regulatory authorities such as the U.S. Food and Drug Administration.
Experience conducting risk analysis and root cause investigations.
Experience performing and interpreting statistical data analysis.
$69500 - $110900 USD Annual
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.
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
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