SOPHiA GENETICS

Quality Associate (temporary 6 months), Lausanne - Switzerland

If you think you fit this position, please send a CV and a cover letter

Assists the Quality Director with the maintenance and improvement of the Quality Management System including:

  • Ensuring the review and timely updating of SOPHiA GENETICS’ Quality Management System per ISO 13485:2016, FDA, MDR and IVDR requirements.
  • Ensuring operating procedures are appropriately documented and comply with ISO13485:2016.
  • Obtaining ISO 13485:2016 re-certification.
  • Monitor, review, update and document relevant processes such as Product Development Lifecycle Management Process, Software Lifecycle Management Process, Document Control, Internal Audits, CAPA, Management Review, Complaint Management, Change Control, etc.
  • Providing technical expertise for current processes and oversees training of department personnel on new processes in collaboration with the Knowledge Management dept. 
  • Preparing and implementing quality assurance policies and procedures.
  • Performing routine inspections on quality documentation and quality tests.
  • Other duties as designated by the Quality Assurance Supervisor.

Requirements:

  • Demonstrated ability and desire to create, improve and optimize an ISO 13485 compliant Quality Management System. 
  • Bachelor's degree in science or engineering(preferably in Life sciences, biology or IT)
  • 2-5 years of experience in quality systems/quality assurance in the medical device industry is preferred. 
  • Strong knowledge of ISO 13485 and 21 CFR part 820
  • Prior knowledge of company, industry, and governmental regulations affecting medical device product development. 
  • Experience with ISO audits is preferred.
  • Demonstrated ability to plan, organize, and self-direct in a rapid and effective manner.
  • Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners
  • Excellent written and oral communication skills;
  • Proficient in English, proficiency in French preferred.

Location : Lausanne - Switzerland

Starting : ASAP

Please note that incomplete applications will not be considered.