Design Quality Engineer (DQE)

- Serve as a Quality subject matter expert in the development of sterile, single-use medical devices, with a focus on packaging, sterile barrier systems, sterilization, and biocompatibility compliance. - Assist in risk management processes per ISO 14971, identifying, analyzing, and documenting risks throughout the design lifecycle. - Contribute to the creation of Use, Design, and Process FMEAs to identify potential failure modes and implement suitable risk mitigation strategies. - Support design verification and validation tasks, including the creation, review, and endorsement of test plans, protocols, and reports, focusing on compliance testing for biocompatible, sterile, single-use products. - Aid in the creation and maintenance of the Usability Engineering File as per IEC 62366 and relevant regulations. - Participate in supplier qualification and process validation efforts, including reviewing supplier documentation and quality results. - Assist in the evaluation, method development, and qualification of test and inspection equipment as necessary. - Support manufacturing transfers, contributing to the creation and review of DMR/DHR documents and the execution or review of validation protocols (IQ, OQ, PQ). - Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to align with validated processes and design specifications. - Collect, analyze, and trend quality and performance metrics to uncover improvement opportunities. - Initiate, lead, and support Corrective and Preventive Actions (CAPAs) to resolve systemic issues. - Take the lead or participate in investigations of product complaints, conducting root cause analysis and documenting findings. - Assist in managing nonconforming materials, collaborating with cross-functional teams to determine suitable actions. - Participate in other quality-related tasks as assigned.