DEPARTMENT OVERVIEW

IEBL advances scalable nanomanufacturing processes and adopts the latest industry techniques and standards in semiconductor and flexible device processing to invent and implement clinical technologies in the future. IEBL has 4,000 sq ft of dedicated laboratory space with extensive in-house bench top, material and device characterization laboratories, a cell culture lab, and an awake rodent animal test lab. The lab also performs device implants in the pig animal model at the Center for the Future of Surgery and the Elliot Field of the UC San Diego as well as manages a smart institutional review board (sIRB) for the authorization for clinical research in patients at UC San Diego Massachusetts General Hospital and OHSU. IEBL is implementing a GMP (Good Manufacturing Practice) cleanroom lab for the development of medical devices for FDA approved clinical research.

In the next few years, the lab will strengthen its partnership with existing clinical colleagues and expand its partnership with other medical centers in the US to address the needs of other neurological indications beyond epilepsy and cancer and to include brain machine interfaces and devices for movement disorders and pain management. The lab will exponentially amplify its impact on clinical care and consumer electronics. It is developing staff to the highest academic and professional standards to lead the future of innovation and dissemination of scientific research and practical products.

POSITION OVERVIEW

The Quality Assurance Specialist II assures the implementation and continued improvement of the IEBL Quality System, quality of products and processes by establishing and enforcing quality standards and testing materials and products. The Quality Assurance Specialist II establishes quality and reliability standards by studying the IEBL’s implantable devices and clinical requirements with other members of management and with production operators, technicians, and engineers and oversees industry-specific practices and ensures all government and company regulations are being met. Their responsibilities include assessing compliance with national and international medical device industry regulations, both external and internal, developing new policies, being the primary contact with medical device contract research and testing organizations for regulatory-compliant product testing, and training employees.

The Quality Assurance Specialist is responsible for the implementation, documentation with Greenlight Guru and oversight of IEBL's quality management system, audit and supplier tasks and activities.

QUALIFICATIONS

• BA/BS in Electrical Engineering or closely related discipline from an accredited University.

• Two-Four (2-4) years’ experience in a Quality position, preferable in Medical Device Implants, and/or certification of training in QMS

• Leadership skills to establish quality and reliability standards in collaboration with the team.

• Quality assurance process skills and the ability to navigate through the steps required by the various regulatory organizations.

• Strong organizational and documentation skills.

• Strong written and verbal communication skills.

• Analytical skills to understand and assess compliance with national and international medical device regulations.

• Ability to collaborate and work with internal and external partners.

• Project Management skills to keep the team on track.

• Ability to thoroughly read, write and understand technical documents.

• Computer knowledge and skills with eQMS and preferably with Greenlight Guru.

• Knowledge of safety requirements and legal standards

• Working knowledge and efficient work in quality system requirements

• Appropriate software e.g. experience with MS Word, Excel, Project Management and Analytics software

• Previous experience in a medical product industry

• Working knowledge with medical device contract research and testing organization.

SPECIAL CONDITIONS

• Job offer is contingent upon satisfactory clearance based on Background Check results.