Principal Quality Engineer

Quality Engineer

Required Skills & ExperienceExperience • Minimum 10+ years of experience in regulated medical device software development. • Demonstrated experience executing or implementing IEC 62304-compliant development processes. • Experience supporting FDA, MDSAP, EU MDR, and ISO 13485 audits. • Experience with process harmonization or separation activities. • Experience working with Class II and/or Class III medical devices.

Required Expertise Strong working knowledge of: • IEC 62304 • FDA Software Guidance • FDA Design Controls • FDA QMSR / 21 CFR Part 820 • ISO 13485 • ISO 14971 • EU MDR • MDSAP • Medical device cybersecurity requirements • Design Control processes • Computer System Validation principles • Software risk management

Job DescriptionWe are seeking an experienced quality engineer to support a strategic separation project focused on harmonizing and updating software development procedures for a global Orthopedics Medical Device organization. The contractor will partner with Quality, Regulatory Affairs, Software Engineering, Product Security, Clinical, and Program Management stakeholders to support the consolidation and standardization of the Software Development Lifecycle (SDLC) framework. The contractor will be responsible for supporting the Quality Engineering Lead by managing the quality deliverables of the program, assessing existing procedures, facilitating review of future-state processes, managing stakeholder alignment, and partnering with the technical writers to deliver an updated set of software development procedures, work instructions, templates, and implementation plans necessary to support an independent quality management system following organizational separation activities.