Staff Software Quality Engineer, Post-Market (Hybrid)

Regulatory Jobs; Flower Mound (TX); Hybrid; USD 113,000 - 188,000; Full time

Job summary

Stryker is hiring a Staff Software Quality Engineer, Post Market Integration for endoscopy and communications. You will lead as a quality engineering expert, driving investigations, CAPA, change management, and continuous improvements across the product lifecycle.

You will partner with R&D, Operations, Commercial, and Quality teams to ensure product reliability, patient safety, and regulatory compliance in a fast-paced, 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

• Lead 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 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 and driving continuous improvement opportunities.
• Analyze quality and operational performance metrics to identify trends 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.

Skills

Quality engineering

Root cause analysis

Risk management

CAPA processes

SDLC knowledge

Education

Bachelor's degree in Science or Engineering

Job description

Stryker is hiring a Staff Software Quality Engineer, Post Market Integration for endoscopy and communications. You will lead as a quality engineering expert, driving investigations, CAPA, change management, and continuous improvements across the product lifecycle.

You will partner with R&D, Operations, Commercial, and Quality teams to ensure product reliability, patient safety, and regulatory compliance in a fast-paced, regulated environment.