Staff Software Quality Engineer, Post Market Integration

Stryker • Flower Mound, TX

1d • $112,900 - $188,100

About The Position

Stryker is hiring a Staff Software Quality Engineer for its post-market integration endoscopy and communications business. In this highly visible role, the engineer serves as a quality engineering leader for commercialized products, driving complex investigations, risk management activities, product quality improvements, and regulatory compliance across the product lifecycle. The role partners closely with R&D, Operations, Commercial, and Quality teams, leveraging software quality, SDLC, and quality system expertise to enhance product reliability, performance, and patient safety.

The position is suited to an experienced quality professional who thrives in a fast-paced, regulated environment and enjoys solving complex technical challenges that directly affect customers and healthcare outcomes. It includes leading complaint investigations, CAPA, change management reviews, continuous improvement initiatives, and quality system activities. The role requires working within hospital and clinical environments, interacting with healthcare professionals, and observing live and simulated surgical procedures. Travel is 30%. The position is hybrid or onsite.

Requirements

• Bachelor’s degree in a science, engineering, or related discipline.
• Minimum of 4 years of experience in a regulated and/or technology-driven industry.
• Proficiency in Software Development Lifecycle (SDLC) processes and methodologies.
• Strong knowledge of quality concepts, such as risk management, CAPA, audits, and statistics.
• Ability to work within hospital and clinical environments, interact with healthcare professionals, and observe live and simulated surgical procedures.
• Ability to obtain and maintain all required credentials for facility access, including applicable health screenings, vaccinations, and background checks.

Nice To Haves

• Experience in the medical device industry, including knowledge of U.S. and international medical device regulations, standards, and quality systems such as ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Working knowledge of computer hardware and related technologies.

Responsibilities

• Serve as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.
• Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.
• Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.
• Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.
• Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.
• Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.
• Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.
• Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.

What This Job Offers

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