Title: Quality Engineer, Level 4
Represent and provide support for the Commercial Product Quality department when working on post market ADVIA Centaur, ADVIA Chemistry, IMMULITE, Automation, Dimension, Vista and INFORMATICS instrument related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field Corrective Action decisions and reporting as required related to HW/SW Laboratory Diagnostics products. Evaluate safety complaint escalations and make decisions on MDR reporting, fully documenting those decisions. Provide support in all areas associated with MDR/MDVR reporting and trending. Provide Commercial Product Quality support for HW/SW Laboratory Diagnostics Product Health Teams. Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.). Expected to perform at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolved complex problems. Provide leadership to the Product Quality Committee in assessing and addressing product defects.
Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected. Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. Experience in Quality Systems, Medical Device Reporting and Field Action recommended.
Good writing, communication and organizational skills necessary.
Job Family Responsibilities: Performs root cause analysis and implementation of corrective action for process related concerns. Assist Quality manager in establishing, implementing and maintaining the quality management system. Develop training to build quality awareness. Conducts economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Develops and provides guidance to multiple operations for QMST. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
Education: BS/BA. Certification may be required in some areas. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.