Assists the Quality Director to ensure that the quality objectives of the company are met ant that the company’s Quality Management System is kept up to date. Key tasks include:
· Ensuring the company’s Quality Management System is kept up to date at all time.
· Ensuring operating procedures are appropriately documented and comply with ISO13485:2016.
· 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.
· Work with internal stakeholders (e.g. Product Development, Data Science, Quality, Supply Chain, Sales, Marketing and IT and Operations) to ensure that quality objectives are met and processes are adequately structured, executed and documented.
· Writing, maintaining and updating quality documents (SOP’s, forms, Work Instructions)
· Providing technical expertise for current processes and oversees training of SOPHiA GENETICS staff 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.
· Participating to or leading internal and supplier audits
· Maintaining contact with notified bodies
· Keep track of the audit agenda making sure that deadlines are met, trainings have been done and projects are not delayed.
· Other duties as designated by the Quality Director.
· Bachelor / Master in a Scientific field (preferably: Biology, Biotech, Bioinformatics)
· Demonstrated ability to manage and optimize an ISO 13485 compliant Quality Management System.
· Working knowledge of ISO 13485 and ISO 14971, FDA QSR, the GxP standards with previous experience in a quality role within the Medical Devices or Pharmaceutical Industry.
· Experience with notified body or regulatory authority audits
· 2-5 years of experience in Quality Assurance;
· Strong written and verbal communication and presentation skills.
· Strong analytical and decision-making skills.
· Strong project management skills.
· Experience with project management tools and process improvement techniques.
· Technical project management or quality engineering experience
· Ability to educate people in Quality Systems and exercise good judgement
· English native speaker; proficiency in French preferred