Senior Software Quality Engineer – Post-Market (Endoscopy)

Stryker; Flower Mound (TX); On-site; USD 113,000 - 188,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker is hiring a Staff Software Quality Engineer for Post Market Integration in endoscopy and communications. You will lead quality investigations, CAPA, and risk management across the product lifecycle to ensure patient safety and regulatory compliance.

In this highly visible role, you will partner with R&D, Operations, Commercial, and Quality teams to drive continuous improvement, support audits, and mentor teams on software quality and SDLC best practices within a regulated environment.

Qualifications

• 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 (e.g. Risk Management, CAPA, Audits, Statistics).
• Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including health screenings, vaccinations, and background checks.

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.

Skills

SDLC knowledge

Quality concepts

Root cause analysis

Education

Bachelor's degree in Science/Engineering or related discipline

Job description

Stryker is hiring a Staff Software Quality Engineer for Post Market Integration in endoscopy and communications. You will lead quality investigations, CAPA, and risk management across the product lifecycle to ensure patient safety and regulatory compliance.

In this highly visible role, you will partner with R&D, Operations, Commercial, and Quality teams to drive continuous improvement, support audits, and mentor teams on software quality and SDLC best practices within a regulated environment.