Quality Manager (Risk Management)
Expiry Date :
Fri, 23 Apr 2021 23:59:59 GMT
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Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organizational skills to help us deliver on our mission of democratising Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.
Be part of our mission to disrupt the healthcare and democratise the data driven medicine! SOPHiA is looking for a Project Manager to join the Quality team in Boston.
The Risk Management Project Manager is responsible for management of Risk activities related to SOPHiA products in adherence to ISO 14971 and FDA/IVDR/MDR requirements.
* Lead and coordinate all risk management activities according to ISO 14971
* Ensure harmonized approaches to risk management across projects.
* Ensure that all hazards associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
* Manage the Risk Management Databank
* Monitor that risk control measures have been implemented, verified and validated
* Collection and systematic review of information about the product in the production and post production phase
* Ensuring complete risk management documentation with responsibility of further developing and implementation ISO 14971 in the internal risk management process for medical devices during their entire life cycle
* SME for Risk Management and will assist design teams and Quality on Risk
* Planning and execution of risk management activities with project managers
* Contribution to continuous improvement of risk management process
* Ensure that risk managements reports are prepared in a timely manner and in accordance with ISO 14971 and applicable company SOP and guidelines and are adequate for inspection by notified bodies, EMEA, FDA and other relevant authorities
* Representation of the risk management in audits and assessment
* 8+ years experience with medical device and member of a design team
* Bachelors Degree required; Advanced degree preferred
* Experience designing medical devices, software as medical device experience preferred
* Good Knowledge of Medical standards: ISO 14971, ISO 13485, IEC 62304, 21CFR 820
* Knowledge in usage of risk assessment methods: FTA, FMEA, PHA
* Knowledge of relevant methods, industry standards and trends within risk management for medical devices including SaMD
* Knowledge of relevant methods, industry standards and trends within information security risk management (ISO/IEC 27001)
* Good English Skills reading, writing, and speaking
* Career opportunities in a fast-growing company with worldwide reputation
* A flexible and friendly working environment with a collaborative atmosphere
* Fantastic office locations in Boston
* 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
Starting date: ASAP,
If you think you fit this position, please send a CV and a cover letter.
Please note that incomplete applications will not be considered.