The Quality Engineer II (QE II) will be an integral member of the BiVACOR quality team in supporting the quality related activities associated with the manufacture, test and distribution of the Total Artificial Heart (TAH) system. The QE II will also work with BiVACOR senior management to implement and supports maintenance of quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806.
The QE II will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The QE II will work with internal engineering staff from mechanical, electrical and software engineering backgrounds to support manufacturing process development and maintenance, The QE II may also assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs.
The QE will act as a liaison between the company and external suppliers to ensure QA activities are sufficiently undertaken to support product development and will identify and record potential problems relating to the product, process and Quality System. QE II will initiate, recommend or provide solutions through designated channels and will then record and/or report all instances of customer feedback on product. QE II will finally verify the implementation of solutions.

KEY RESPONSIBILITY AREAS

This job description has been designed to indicate the general nature and level of work performed by a Quality Engineer II. It is not designed to contain or be interpreted comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the role.

Please refer the Job description for details