Sr. Software Quality Engineer

Primary Duties & Responsibilities

• Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366-1 and other relevant standards
• Support the product development team in creation of design history files (DHFs) including product requirements, software architecture and design specifications, design verification and validation test protocols and reports, risk management file, cybersecurity documentation, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971
• Guide and lead computerized system assurance and validation activities for SW tools and systems.
• Engage and collaborate with suppliers and support design, development and design transfer activities.
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
• Support root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization

Qualifications

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Computer Science, Electrical, or related field).
• 8+ years of quality engineering or in medical device development from concept development to production release.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment
• Experience with software V&V activities, experience with AI/ML technology is a plus
• Hands-on experience with risk management tools (e.g. FMEA, risk analysis) and design controls
• Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment

Skills and Abilities

• Proficient in working in eQMS tools with impeccable documentation skills
• Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies
• Strong analytical skills and excellent problem-solving skills
• Exceptional organizational skills and attention to detail