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 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
