For our customer located in Basel/Switzerland we are currently looking for a: Medical Device Technical Expert (m/f/d)
- Location: CH-4056 Basel
- Branch: pharma
- Duration: 6 months +
Tasks & Responsibilities
Medical Device expertise related to Quality Assurance activities associated with the maintenance of medical devices, with a focus on MDR Class IIa inhalers, for which the client is the Legal Manufacturer. Activities include QA oversight and approval of the Design History File and Device Master Record, approval of design changes, QA approval the associated with change request cases, involvement on technical issues associated with the device portfolio, represent QA in the Post Marketing Surveillance activities, interactions and quality monitoring of third party companies involved in the manufacturing, maintenance of the Quality Agreements with third parties, contribute with the periodic management reports, support in the maintenance of the QMS, support in the maintenance of the ISO 13485 and EU MDR certification.
- Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
- Desirable: Advanced degree in scientific or relevant discipline
- Fluency in English, additionally one or more of the regional (local) site languages a plus
- at least 3 years of work industry experience or equivalent experience in a related industry
- Excellent knowledge and understanding of the relevant requirements for design controls, as well as all QMS requirements for medical devices
- Evaluation, problem-solving, and decision-making abilities
- Excellent teamwork in multidisciplinary and multicultural environment
- Demonstrated ability to collaboratively work in an interdisciplinary and multicultural team
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.