RIT Solutions, Inc.
Key Responsibilities: Execute testing of electrical, mechanical, and software components and systems as applicable. Follow test protocols; execute testing; complete verification and validation activities Assist in identifying, recommending, implementing, managing, and administering process and software validation. Participate in internal and external audits.We're Looking For: 3+ years' experience in Quality assurance including medical device design controls. Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1 Solid understanding of IEC 62304 Medical Software Development Process Familiarity with Risk Management standards ISO 14971 Excellent analytical and decision-making skills, as well as strong written and verbal communication Ability to speak effectively before groups of clients or employees. Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus. Experience in modern test automation is a plus.