We are looking for a smart and dynamic Quality System Manager with a proven track record with managing Quality Systems in medical device/IVD to join the quality team of SOPHiA GENETICS.
As a Quality System Manager you are the Global Quality System process owner, you develop and implement Quality System strategy and architecture for the company and ensure regulatory compliance for corporate Quality System. You have operational responsibility for the Corporate Data and Document Management organizations, manage the Quality Systems Council (QSC) and CAPA and coordinate the Management Review and global Quality Scorecard.
Additionally, you manage corporate regulatory inspections, internal audits and audit preparedness and readiness. You are the liaison with sites on NB,FDA, and other regulatory agency audits/inspections and responses.
- Thorough knowledge and understanding of medical device regulations and standards, including but not limited to QSR, MDD/MDR,IVDD/IVDR, ISO Quality System and other applicable industry requirements is required.
- Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
- Must have ability to make effective presentations to all levels of the organization.
- Proven ability to prioritize and manage multiple projects and meet deadlines is required.
- Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
- Experience managing a team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
- Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.
- Experience 7+ years in medical device industry
- University degree
- Proved record of managing audits
- A competitive compensation package.
- A flexible and friendly working environment with a collaborative atmosphere
- Fantastic office locations in Switzerland, France, and USA.
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
Start: ASAP (or as agreed)
Contract type: CDI full-time (permanent contract)
If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.
After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.