Design Quality Engineer

Solothurn  ‐ Vor Ort
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Beschreibung

You are an outstanding Quality Engineer with experience in the pharmaceutical area especially in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client one of the biggest pharmaceutical companies worldwide needs you for a 6 months TRD project. The Technical Requirement Document (TRD) is a CFDA submission. Within this project our client needs to review its Design Requirements against the current China GB/YY standards and the submitted TRD documentation and update the TRD as needed.

Your duties and responsibilities:

  • Within the Design Quality team you're focusing on life cycle management activities
  • You're enhancing the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement
  • You're applying statistical methods and processing/designing excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies
  • You' re providing leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc
  • You're providing leadership in the understanding of medical device regulations to other disciplines
  • You know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times

What we require:

  • A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required
  • Proven exceptional written and oral presentation skills
  • Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required
  • Previous Quality Engineering experience is preferred
  • Experience in a Medical Device regulated environment
  • Fluency in English is required, good knowledge of German would be a strong asset

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you.

Start
02.05.2018
Dauer
6 months
Von
Harvey Nash IT Recruitment Switzerland
Eingestellt
20.04.2018
Projekt-ID:
1541833
Vertragsart
Freiberuflich
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