Staff Software Quality Engineer, Post Market Integration

Experteer Overview As Staff Software Quality Engineer, you will lead quality engineering for post-market software in endoscopy and communications. You will drive complex investigations, risk management, CAPA, and regulatory compliance across the product lifecycle, partnering with R&D, Operations, Commercial, and Quality. You’ll influence design reviews, change management, and continuous improvement to boost reliability and patient safety. This role combines hands-on problem solving with cross-functional leadership in a fast-paced, regulated environment. Compensation / Benefits * Serve as subject matter expert for quality engineering; lead investigations, root cause analysis, risk management, and system-level problem solving * Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes * Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions on product and process quality issues * Review and influence change management, design and development activities; identify risks and drive improvements * Analyze quality and operational metrics to identify trends, prioritize actions, and improve product quality and compliance * Apply risk management, human factors, statistical methods, and quality engineering principles to development, validation, usability, and lifecycle 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; mentor within the organization Tasks * Bachelor in Science, Engineering or related discipline * Minimum of 4 years in a regulated and/or technology-driven industry * Proficiency in Software Development Lifecycle (SDLC) processes and methodologies * Strong knowledge of Quality Concepts (Risk Management, CAPA, Audits, Statistics) * Ability to work in hospital/clinical environments and obtain/maintain credentials for facility access (health screenings, vaccinations, background checks) Key requirements *

_ Review and influence change management, design and development activities; identify risks and drive improvements * Analyze quality and operational metrics to identify trends, prioritize actions, and improve product quality and compliance * Apply risk management, human factors, statistical methods, and quality engineering principles to development, validation, usability, and lifecycle 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; mentor within the organization Tasks * Bachelor in Science, Engineering or related discipline * Minimum of 4 years in a regulated and/or technology-driven industry * Proficiency in Software Development Lifecycle (SDLC) processes and methodologies * Strong knowledge of Quality Concepts (Risk Management, CAPA, Audits, Statistics) * Ability to work in hospital/clinical aa customers, and obtain/maintain credentials for facility access (health screenings, vaccinations, background checks) Key requirements *