Job Description
**Staff Quality Engineer – Flower Mound, TX**
At Stryker Communications (https://www.stryker.com/us/en/communications.html) , 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 w...
At Stryker Communications (https://www.stryker.com/us/en/communications.html) , 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 w...