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 democratizing Data-Driven Medicine. Our products are used by nearly 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 traditional healthcare model and democratize data driven medicine! SOPHiA GENETICS is looking for an experienced Design Assurance Specialist (Quality Specialist) to join the Quality Assurance and Regulatory Affairs (QAamp;RA) teams at our headquarters in Rolle (CH), or in Bidart (FR)
The Design Assurance Specialist will be responsible to help design teams be compliant with design controls, risk management and SDLC requirements. They provide quality technical support and guidance to design teams and maintain design documentation to meet quality and regulatory requirements such as ISO 13485, IVDR, IEC 62304 and FDA QSR.
Responsibilities:
- Actively participate to international project teams to develop software as a medical device and in vitro diagnostic devices by providing necessary Quality Systems guidance.
- Review, assess and approve product design milestones and deliverables across product development cycle to ensure compliance to customer and regulatory requirements.
- Leading Design reviews to ensure that all required deliverables are met and documents are approved and properly referenced.
- Review and approve design changes to ensure that the device remains safe and effective throughout its lifecycle.
- Maintain the Risk Management File and Design History File of the devices.
- Participate in internal and external audits as Subject Matter Expert.
- Support the Regulatory Affairs department with the submission process.
- Provide guidance to teams for other development projects (Research Use Only, Investigational Use) when needed.
Requirements
If you are a self-starter with excellent communication skills and are motivated to work hard and have an affinity for highly detailed work, this position may be a very good fit for you. The best candidate will be knowledgeable on software development processes in regulated environments, design controls and being able to work in highly diverse design teams.
- 3-4 years’ experience working on software products within a quality or regulatory system.
- Familiarity with software development practices and technical software development concepts and tools.
- Knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA QSR.
- Experience in the execution of design controls.
- Background in being autonomous and being able to clearly work towards established goals and initiatives with minimal guidance.
- A high attention to detail and ability to prioritize.
- Pro-active problem solver, working with projects to balance quality, cost, and timelines while remaining compliant.
- Ability and willingness to learn/ use new software applications. Experience with Veeva and/or Jira a plus.
- English is mandatory, any other language is a nice-to-have
Benefits
You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.
Business recognition and accolades include:
- World's most innovative companies (Top 10)
- World's smartest companies (Top 50)
- 100 Best Places to Work in Boston
- Top 10 European Tech Startup - 2020
- Top 10 European biotechs startup to watch - 2021
- Top 25 East-Coast Biotech to watch - 2021
Plus, you will find :
- A flexible, friendly, and international working environment with a collaborative atmosphere
- Flexible working hours, including hybrid remote / on-site working model
- 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
- A hard technical challenge to solve with exciting modern technology - cloud computing, Big Data, DevOps, machine learning
Location: Rolle (CH) or in Bidart (FR). Office-based, including 2 days per week remote / 3 days on-site.
Start: ASAP (or as agreed)
Contract type: Permanent, full-time
Application process
If you think you fit this position, please send a CV and