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Lead Auditor- Center of Excellence MED

Published : 12/01/2023

Location : USA

Career Level : Successful completion of a university degree in technical, medical or applied sciences studies or equivalent professional qualification in relevant courses, e.g. medicine, pharmacy, engineering or other relevant science; in individual cases: conclusion as instead. Certified technician with additional work experience; Four years of professional experience in the field of health products or related activities such as manufacturing, testing or research (reduced / additional work experience depending on qualification) Of which two years in the field of design, manufacture, testing or application of the product or technology to be assessed or in connection with the scientific aspects to be assessed; Knowledge of product legislation, including the essential safety and performance requirements stated within Appendix I. Adequate knowledge and experience in the field of relevant harmonized standards, specifications and guidelines, as well as risk management and the related standards and guidelines for products; Adequate knowledge of quality management and related standards and guidelines; Adequate knowledge and experience in the field of clinical evaluation; Adequate knowledge of the products to be assessed Adequate knowledge and experience in the field of conformity assessment procedures described in Annexes IX to XI and in particular the aspects of those procedures for which the personnel is responsible, as well as the corresponding authority to carry out these procedures / audits; Further training in the area of audit procedures, which enables the staff to critically examine quality management systems; The ability to produce protocols and reports that demonstrate the appropriate conduct of the relevant conformity assessment activities

Entity : Auditor

Type of employment : 40

Reference number : 1143

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Challenging. Competent. Dynamic: DQS Inc. - Business Area Medical Devices, is committed to the sustainable success of companies worldwide, through the value-added auditing of management systems and the approval of medical devices. Our main focus are long-established services in the area of quality/risk management in healthcare and medical device safety.

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We cultivate a corporate culture in which our employees feel comfortable. It is important to us to offer you a pleasant working atmosphere. In addition to attractive tasks, we offer our employees the following social benefits