Quality Assurance - Medical Device - Technical Expert

☞ Randstad Switzerland

View: 150

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job content

For one of our client in Basel we are looking for a Medical Device Technical Expert for a project until end of the year at 50%

Description

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 our 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
Languages: Fluency in English, additionally one or more of the regional (local) site languages a plus

Experience: 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 a multidisciplinary and multicultural environment.
  • Demonstrated ability to collaboratively work in an interdisciplinary and multicultural team.
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Deadline: 10-05-2024

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