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Design Quality Engineer: FDA, ISO 13485, 14971, FTA, FMEA, Haccp

Eingestellt von Sentinel IT LLP

Gesuchte Skills: Design, Engineering, Engineer

Projektbeschreibung

Design Quality Engineer:FDA, ISO 13485, 14971, FTA, FMEA, HACCP

I have a lovely opportunity to work in a beautiful location for a well respected medical device company. They are looking for a design quality engineer to provide quality engineering support in design and development of medical device products, specifically ventilators. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.

Key experience/skills required:

Education/Experience:
*BS with 3-5 years

Desirable but not essential:
*MS with 0-3 years
*Phd

Skills/Qualifications:
*Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
*Good verbal and written communication skills including protocol/report development and technical presentations.
*Risk Management, ISO 14971, FTA, FMEA, HACCP.
*Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.

Please apply with a relevant and up to date CV for a more detailed job description.

Design Quality Engineer:FDA, ISO 13485, 14971, FTA, FMEA, HACCP

Projektdetails

  • Einsatzort:

    Irland

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Sentinel IT LLP