Job Description
Work Flexibility:
Hybrid Staff Quality Engineer - Flower Mound, TX At Stryker Communications, quality is central to how products are developed, launched, and supported globally. This role sits at the intersection of product quality, regulatory compliance, and data-driven decision making—supporting post-market engineering activities while leading improvements across systems and processes. You will work across teams to ensure product performance, complaint handling, and reporting meet global standards. What you will do Review customer complaints and determine reportability to regulatory authorities, including FDA and international bodies Support preparation and submission of Medical Device Reports (MDRs) and international vigilance reports in accordance with regulatory timelines Lead investigations into post-market product issues, including developing and executing test plans and documenting results Partner with engineering teams to implement and validate design and engineering changes based on field performance and complaint trends Act as the post-market quality owner for the Tables Product Line, driving improvement across mechanical and electromechanical systems Partner with sales teams and healthcare professionals to gather complete complaint data and drive investigations to timely, high-quality, and actionable outcomes Develop customer response letters aligned to investigation findings and regulatory requirements Build and maintain dashboards and reports using data from systems (e.g., quality databases), translating data into actionable insights Author and review post-market surveillance plans and reports for products distributed globally Lead risk management activities and quality system improvements by identifying gaps, implementing corrective actions, and partnering with cross-functional teams on product and process enhancements What you will need Required qualifications: Bachelor of Science in Engineering or related technical discipline Minimum 4 years of experience in Quality Engineering within a regulated industry. Medical device manufacturing is strongly preferred. Preferred qualifications:
Familiarity with quality standards and regulations (e.g., ISO 13485, GMP, GDP) Experience with statistical analysis and risk-based methodologies Experience with data visualization and reporting tools (e.g., Power BI) Experience supporting post-market surveillance or complaint handling processes Experience supporting engineering changes and product investigations Experience working with mechanical or electromechanical systems US10: $98,200 - $163,700 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. 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.
