Posted 2 weeks ago

Quality Assurance Engineer (Onsite)

Stryker Employment Company, LLC United States of America, Texas, Flower Mound 571 Silveron Blvd
Onsite Full Time

Job description

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 Stryker's 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 Bachelor’s 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: $76,500 - $122,000 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 contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.