Study Director Biocompatibility

  • Salary: 90-100 CHF per hour
  • REF Number: 00048370
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 12.06.2020
  • Sector: Medical Devices
  • Location: Central Switzerland
  • Discipline: Science - Microbiology

CK QLS are recruiting for a Study Director Biocompatibility to join a company leading medical device company at their site based in Oberdorf on contract basis for 6 months, with the possibility of extension.

Study Director Biocompatibility Role:The main purpose of the role will be to:

  • Plan, coordinate and implement of all activities for Biological Safety Evaluation of Medical Devices according ISO 10993 and maintain compliance in accordance with the new EU Medical Device Regulations.
  • Evaluate the required material and influencing the product quality, particularly in the area of biocompatibility.
  • Assign, co-ordinate and interpret product testing in internal and external laboratories in the field biocompatibility and chemical analyses.

Further responsibilities will include:

  • Reviewing laboratory data for accuracy, consistency and completeness; identifying results with potential issues requiring further investigation.
  • Creating Reports and Rationales.
  • Updating, maintenance or rebuilding of work instructions and other for Quality relevant documents in the document management systems.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Previous experience in European Medical device industry especially with Regulatory, Quality or Engineering.
  • Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • Knowledge of ISO 10993-1 is an advantage.
  • Experience in Good Manufacturing Practice (GMP).
  • Background in process and cleanliness validation.
  • German skills would be a strong asset.

The Benefits: This is an excellent opportunity to join a leading medical device company.

Apply: For more information or to apply for this Study Director Biocompatibility position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 48370.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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