Software Quality Assurance Engineer

Looking to step into a new Software Quality Assurance role at a thriving medical device company based in Northern California? This could be your chance to progress in an excellent team with a strong mission statement. The role includes:

Areas of Responsibility:

• Lead multi-functional discussions/investigations to ensure safety and quality of software products
• Participate and represent QA during FDA and NB site audits
• Prepare/review/approve quality-related and design documents
• Participate and provide QA oversight/support throughout product development
• Support post-market activities, manufacturing/equipment qualification, and process control/training programs
• Represent QA in new product development project teams, ensuring regulatory compliance and SDLC adherence
• Support maintenance of product/quality system compliance

Requirements:

• Strong project management skills, including leading cross-functional teams, developing project scope/tasks/deliverables, and risk management identification/mitigation
• Working knowledge of collateral standards (IEC 60601-1, IEC 62366, etc.)
• Expertise in IEC 62304, design control, verification, defect reporting, risk analysis, computer system validation, and audits
• Ability to lead software requirements/specifications review, risk analysis/assessment, and testing efforts for verification/validation
• Experience in creating test plans/reports, reviewing QTs and trace matrices, and conducting formal software verification design reviews
• 5-10+ years software application experience in the medical device industry (mandatory)
• In-depth knowledge and experience in software quality assurance for medical devices/SaMD, operations, manufacturing, and regulations (21 CFR Part 820, 21 CFR Part 11, and ISO 13485:2016)