Engineer II, Quality - CR (Shift C)

Support the development and manufacturing of existing and new introduction of medical devices. Work with Manufacturing and R&D to resolve product quality issues, which may include field complaints. Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties: Work with manufacturing engineers to review process changes, resolve product quality issues, and assess related risks.

Work with suppliers to maintain high quality levels of incoming production materials. Participate in quality audits of suppliers, if required. Work with R&D engineers to support implementation of new products by reviewing quality and testing plans. Work with R&D manufacturing engineers to develop the FMEAs, as required.

Works with R&D and manufacturing engineers to develop test protocols and reports (e.g., design verification, design validation, process qualification, and process validation) and review their proper execution. As assigned, maintain various Quality Systems such as CAPA, Non-Conformance (NCR), Supplier Quality, equipment calibration, internal auditing, and quality metrics data analysis.

Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned.