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.
- 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.