Posted to MedZilla on 8/17/2017

Phaidon International

US-, Freelance Quality Assurance Manager - 6 month - Switzerland 452431235868-MZ


 
 

Freelance Quality Assurance Manager - 6 month contract - 1.0FTE - Office-based, Switzerland

My client, who is a global pharmaceutical company, is looking for a freelance Quality Assurance Manager for a 6 month contract, starting in July 2015. This will be a full time (1.0FTE), office based role located in the French part of Switzerland. 

 
Main responsibilities for a Freelance Quality Assurance Manager:

  • Design Control
Ensure design control compliance
Identify applicable quality and regulatory requirements.
Review and approve all project deliverables (internal and from suppliers).
Participate to risk management and usability engineering processes in accordance with ISO 14971 and IEC 62366.
Participate to design reviews, approves/disapproves move to next phase.

  • Regulatory Support
Compile the Technical File, ensure CE mark approval.
Support regulatory submissions worldwide.
Ensure alignment with drug development and regulatory teams.

  • Quality Assuranc
Participate to supplier qualification and audits.
Review and approve change control, deviations and CAPAs.
Assess new or revised regulations and standards.

Skills/Experience required for a freelance Quality Assurance Manager:
  • At least 5 years of experience in Quality Assurance and Regulatory Affairs .
  • Extensive medical device experience.
  • Medical device and drug-device combination regulations for the EU and US.
  • Design control process and risk management experience.
  • GMP experience (ISO 134858).
  • Ability to manage and lead all QA aspects. 
  • Fluent in English.
If this Freelance Quality Assurance Manager opportunity is of interest to you, please send your CV to Huyen.Pham(at)EPMScientific.com or call +44 203 758 8944 immediately.

Please visit our website at www.phaidoninternational.com

 
 


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