Leader Auditor for MDSAP

We are searching for engaged professionals, aligned with BV values, and that want to grow with us, to act as a Leader Auditor in international market.

About NCC/Bureau Veritas:

A NCC Group is a certification company and testing laboratory and we are part of the global Bureau Veritas.

The BV was founded in 1828, and is dedicated to certification and conformation evaluations services around the world and is the global leader in Testing, Inspection and Certification, in areas such as Quality, Safety, Health, Environment, Social Responsability, etc.

Together, we are prepared to anticipate the market trends and customers demands for value added services on an international scale.

Responsabilities:

Leader auditor: an individual responsible for leading the audit team; The lead auditor manages an audit team, prepares the audit plan, evaluation of the applicable items during the audit; conducts any audit related meetings, and reviews and submits the formal audit report; comply with the deadlines stablished by the program and NCC.

Auditor: evaluation of the applicable items during the audit; share the information audited with the leader auditor; comply with the deadlines stablished by the program and NCC.

Pre-requisite Education:

. Diploma or degree from a university or technical college in medicine, science, or engineering (educational requirement). Disciplines of interest include, for example;  Biology, Microbiology,  Chemistry, Biochemistry, Computer hardware and software technology, Material sciences, Engineering - electrical, mechanical, biomedical, clinical, bioengineering,  Human physiology, Medicine, Pharmacy, Physics and biophysics.

Relevant work experience

Lead auditors and auditors must demonstrate at least four years of full-time relevant experience in one or more of the following areas:

• Design and development, production, manufacturing and quality control of medical devices;
• o Study of a medical device technology and its application;
• Conducting tests on a medical device in accordance with national or international standards;
• Performance testing, evaluation studies or clinical trials of a medical device.

Training and professional development

• 40 hours of lead auditor training in Quality Management System.
• 8 hours of training in ISO 13485;
• 32 hours of training in medical device regulations (MDSAP Audit Approach);
• 8 hours of training in risk management, related to project and QMS;
• Statistical analysis;
• Product, process or standards knowledge requirements.