Leader Auditor For Mdsap

Detalhes da Vaga

We are searching for engaged professionals, aligned with BV values, and that want to grow with us, to act as a Leader Auditor in the international market.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 Responsibility, etc.Together, we are prepared to anticipate the market trends and customers demands for value-added services on an international scale.Responsibilities:Leader Auditor: An individual responsible for leading the audit team; the lead auditor manages an audit team, prepares the audit plan, evaluates the applicable items during the audit, conducts any audit-related meetings, and reviews and submits the formal audit report; complies with the deadlines established by the program and NCC.Auditor: Evaluation of the applicable items during the audit; shares the information audited with the leader auditor; complies with the deadlines established 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.Experience Requirements: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;Study of 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.Come to be part of our team. Together we can develop a world of trust, ensuring responsible progress!
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