Staff Quality Engineer

Stryker • Flower Mound, TX

6d • $98,200 - $163,700 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level