Stryker is hiring a Quality Assurance Engineer for our Global Quality Operations team in Flower Mound Texas.
This is an onsite position based in Strykers Flower Mound office five days per week.
As the Quality Assurance Engineer you will provide quality engineering support in quality assurance control and preventative activities with a focus on continuous improvement of products and processes. You will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers ensuring compliance to regulation and standards.
What You Will Do
Collaborate with operations and cross-functional teams to ensure product and process quality meets defined standards and specifications
Review and approve nonconformance and corrective/preventive action records ensuring timely closure and effectiveness tracking
Analyze quality data and maintain key performance indicators to monitor trends identify root causes and reduce defects
Support change management processes by evaluating quality impact and ensuring compliance with procedures
Participate in internal and external audits provide documentation and address audit observations within required timelines
Conduct risk assessments and support validation activities to ensure manufacturing processes meet regulatory and quality requirements
Partner with engineering and commercial teams to investigate customer complaints and implement corrective actions
Drive initiatives to improve inspection methods reduce nonconformances and enhance overall product quality performance
What You Need
Required
Bachelors degree in engineering
Proficiency with standard computer applications
Strong communication project management and influencing skills as well as the ability to manage multiple tasks simultaneously
Preferred
Familiarity with quality concepts such as risk management corrective and preventive actions and statistical analysis
Knowledge of medical device regulations and standards including ISO 13485 and Good Manufacturing Practices (GMP)
Experience supporting audits or interacting with regulatory agencies (FDA MoH TUV etc.)
US10: $76500 - $122000 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: OnsiteStryker is hiring a Quality Assurance Engineer for our Global Quality Operations team in Flower Mound Texas.This is an onsite position based in Strykers Flower Mound office five days per week.As the Quality Assurance Engineer you will provide quality engineering support in qu...
Work Flexibility: Onsite
Stryker is hiring a Quality Assurance Engineer for our Global Quality Operations team in Flower Mound Texas.
This is an onsite position based in Strykers Flower Mound office five days per week.
As the Quality Assurance Engineer you will provide quality engineering support in quality assurance control and preventative activities with a focus on continuous improvement of products and processes. You will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers ensuring compliance to regulation and standards.
What You Will Do
Collaborate with operations and cross-functional teams to ensure product and process quality meets defined standards and specifications
Review and approve nonconformance and corrective/preventive action records ensuring timely closure and effectiveness tracking
Analyze quality data and maintain key performance indicators to monitor trends identify root causes and reduce defects
Support change management processes by evaluating quality impact and ensuring compliance with procedures
Participate in internal and external audits provide documentation and address audit observations within required timelines
Conduct risk assessments and support validation activities to ensure manufacturing processes meet regulatory and quality requirements
Partner with engineering and commercial teams to investigate customer complaints and implement corrective actions
Drive initiatives to improve inspection methods reduce nonconformances and enhance overall product quality performance
What You Need
Required
Bachelors degree in engineering
Proficiency with standard computer applications
Strong communication project management and influencing skills as well as the ability to manage multiple tasks simultaneously
Preferred
Familiarity with quality concepts such as risk management corrective and preventive actions and statistical analysis
Knowledge of medical device regulations and standards including ISO 13485 and Good Manufacturing Practices (GMP)
Experience supporting audits or interacting with regulatory agencies (FDA MoH TUV etc.)
US10: $76500 - $122000 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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