Staff 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.

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

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