Category
Ingenieurswesen & Produktion
Job Reference Number
JN-062021-181504
KANTON
Vaud

Our client is an innovative medical device company settled in Canton of Vaud.

Responsibilities :

  • Manage the quality strategy for a new site manufacturing site implementation and qualification;
  • Lead change control strategy by reviewing requirements, specifications and technical design documents;
  • Participate to validation and commissioning activities;
  • Lead quality input to validation protocols, reports and investigate the causes of non-conforming activities;
  • Be the Notified body main contact for audit and related support for certification;
  • Interact with Management team providing quality KPIs;
  • Ensure compliance with QMS for new manufacturing site;
  • Participate to improve quality process.

Profile :

  • Bachelor's degree in Science, Engineering, Biotechnology, Quality Management;
  • Justify at least a minimum of 10 years of similar experience in quality project management;
  • Capacity to lead strategies for risk management, deviation, CAPA project activities;
  • Relevant expertise in cGMP standards for FDA, MHRA and EU regulatory approval;
  • Certification activities for new site ISO 9001 & ISO 13485.

Permanent contract - Please send us a PDF format CV #boost