Staff Software Quality Engineer - Post-Market Medical Devices

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

Job summary

Stryker is seeking a Staff Software Quality Engineer for Post Market Integration in the endoscopy and communications space. This role partners with R&D, Operations, Commercial, and Quality to drive investigations, CAPA, and robust change management across the product lifecycle.

With 4+ years in regulated industries and strong SDLC knowledge, you will apply risk management and quality system expertise to enhance patient safety, product reliability, and regulatory compliance in a fast-paced

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 procedures, and obtain/maintain credentials.

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

Quality concepts

Risk management

CAPA

Audits

Statistics

Education

Bachelor's degree in Science or Engineering

Job description

Stryker is seeking a Staff Software Quality Engineer for Post Market Integration in the endoscopy and communications space. This role partners with R&D, Operations, Commercial, and Quality to drive investigations, CAPA, and robust change management across the product lifecycle.

With 4+ years in regulated industries and strong SDLC knowledge, you will apply risk management and quality system expertise to enhance patient safety, product reliability, and regulatory compliance in a fast-paced