Product Assessor and Lead Auditor on Medical Devices
vor 1 Woche
CSI is an European center of reference for the verification and certification of the conformity of materials, products, systems and companies. CSI is a cutting-edge facility, composed of test laboratories, analysis centers and testing tracks, equipped with advanced equipment and devices for diagnosis, analysis and data processing. For over 25 years, CSI has been recognized as a center of excellence, particularly for companies in the food, packaging, materials, construction and automotive sectors. Our commitment is aimed at enhancing quality companies and protecting the market, guaranteeing high standards and compliance with European regulations.
Product Assessor and Lead Auditor on Medical Devices:
IMQ CSI Deutschland GmbH, due to the expansion of its workforce, is looking for a Product Assessor and Lead Auditor on Medical Devices.
Main Duties and Responsibilities:
Responsible for the documentary assessment of Medical Device Technical Files.
Conduct on-site audits for CE marking (MDD - medical devices directive and MDR- medical device regulation) and ISO certification schemes.
Conduct on-site audits for MDSAP.
Prepare detailed reports on the evaluation activities performed.
Available for international business travel.
Knowledge and Skills:
In-depth knowledge of EU Regulation 2017/745 (MDR), MDSAP (Medical Devices Single Audit Program) and ISO 13485 standards.
Fluent in English and with B2 level knowledge of the German language
Proficient in Windows applications.
Ability to draft reports using appropriate technical and scientific language.
Abilities and Attitudes:
Proactive and well-organized.
Team-oriented and collaborative mindset.
Strong communication skills and customer focus.
Flexible and adaptable.
Ability to work effectively under pressure.
Education and Professional Requirements:
Professional background
Similar experience at a Notified Body in the field of active and non-active medical devices.
Education:
University degree in engineering or other technical disciplines.
Job location: Munich (Germany)
IMQ CSI Deutschland GmbH offers a permanent contract with a salary appropriate to the experience gained.
The job offer is aimed at both genders.
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