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Design History Files Expert - Medical Devices

Eingestellt von Michael Bailey Associates - Munich

Gesuchte Skills: Design, Engineering

Projektbeschreibung

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, eg syringes and cartridges;
- General understanding of pharmaceutical development;
- General understanding of Human Factors Engineering and Risk management.

Kontakt: luchele mendes or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    07/2019

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Michael Bailey Associates - Munich