Quality Engineer

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.

• 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.

• 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.

• 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

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