Job Details

Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities. Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gileads quality system requirements. Plan and implement approved quality improvement action items and deliverables. Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products,processes, and quality. Act as an escalation point for complex and high-impact quality issues, concerns, and decisions. Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMO...Product Development, Quality Engineer, Engineer, Development, Quality, Product, Technology