Senior Quality Assurance Engineer

Sr. Quality Engineer (Surgical Robotics / Design)Job DescriptionWe are seeking a Senior Quality Engineer to support the development and lifecycle management of complex medical devices in a highly regulated environment. This role will serve as a key quality partner to engineering and product development teams, helping ensure quality is built into products from concept through commercialization.The ideal candidate will bring hands-on experience supporting electro-mechanical and software-enabled medical devices, with a strong background in design quality, risk management, validation, and regulatory compliance. This individual should be comfortable wearing multiple hats across design, development, manufacturing, and post-market quality functions.This is a high-impact role for someone who has personally owned quality activities within product development environments and can operate effectively across cross-functional teams.Day-to-DayAct as the Quality representative on new product development and sustaining engineering programsApply design controls throughout the product development lifecycle for hardware, software, and electro-mechanical medical devicesEnsure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality systemsLead and author validation documentation including process, software, equipment, and verification/validation reportsSupport Design History File (DHF), design reviews, change control, and product release documentationDrive risk management activities using ISO 14971, ensuring hazards are identified and mitigated appropriatelyParticipate in root cause investigations, CAPA activities, and implementation of corrective actionsSupport internal/external audits and FDA inspections, serving as a subject matter expert when neededPartner with engineering teams to ensure quality is integrated early into product design and developmentSupport usability, biocompatibility, electrical safety, and software compliance activities as applicableRequirements / QualificationsBachelor’s degree in Engineering or related technical discipline5+ years of Quality Engineering experience within the medical device industryStrong experience supporting product development/design environments, not just manufacturing qualityExperience with complex electro-mechanical medical devices, capital equipment, robotics, or combination products strongly preferredWorking knowledge of FDA 21 CFR Part 820 and ISO 13485Hands-on experience applying ISO 14971 risk management during product developmentExperience leading validation efforts (process, software, equipment, test method, or product validation)Strong knowledge of design controls, DHF documentation, design reviews, and engineering change processesExperience participating in FDA inspections and/or ISO auditsRoot cause analysis and problem-solving experience in regulated environmentsStrong communication skills and ability to influence cross-functional teamsNice to HaveRobotics or surgical system experienceExperience with IEC 62304 (software lifecycle)Experience with IEC 60601 (electrical safety)Experience with ISO 10993 (biocompatibility)Experience with ISO 62366 (usability engineering)Lead Auditor or CQE certification