Design History Files Expert - Medical Devices

Basel-Stadt  ‐ Vor Ort
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Beschreibung

We are recruiting for a Design History File Expert for my medical device client on a contract basis. You will be supporting technical activities within the development of parenteral drug delivery systems (combination devices) such as pre-filled syringes and injections.

Responsibilities:
  • Ensure product compliance for the assigned projects
  • Compile Design Control documentation and contributing to a high quality Design History file.
  • Establishes/Participates in the documentation strategy
  • Support of development of Quality Assurance Agreements with third parties.


Requirements:
  • Bachelor's or Masters in Engineering with at least 5 years of experience in a similar area
  • Pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up;
  • Medical device quality assurance;
  • DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects;
  • Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
  • Background in mechanical engineering in general
  • Product design/Design for manufacture
  • Test and verification, incl. development of methods and equipment
  • Experience in medical device quality assurance;
  • Good communication and conflict solving skills;
  • Good technical knowledge in primary containers, e.g. syringes and cartridges;
  • General understanding of pharmaceutical development ;
  • General understanding of Human Factors Engineering and Risk management.

    Kontakt: luchele.mendes (at the rate of) mbaswitzerland.com or call


Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
08/2018
Dauer
07/2019
Von
Michael Bailey Associates
Eingestellt
31.07.2018
Projekt-ID:
1607186
Vertragsart
Freiberuflich
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