Quality Associate

Vor 4 Tagen

Lausanne, Schweiz SOPHiA GENETICS External Vollzeit

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 organisational 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 traditional healthcare model and democratise data driven medicine SOPHiA GENETICS is looking for an experienced Quality Associate (Design Assurance Lead) to join the Quality Assurance and Regulatory Affairs (QA&RA) teams at our headquarters in Saint-Sulpice, Switzerland.
The Design Assurance Lead will be mainly focused on helping design teams be compliant with design control requirements. They maintain design documentation for Design History File to meet Design Control requirements as required per FDA QSR and ISO 13485/IVDR/MDR.

**MAJOR DUTIES AND RESPONSIBILITIES**:
Participate to international project teams to develop medical and in vitro diagnostic devices (e.g. software and kits), providing necessary guidance and support to meet design control requirements per FDA QSR and ISO 13485/IVDR/MDR including:
Continuous improvement of design and development procedures and their documentation, including software lifecycle following IEC-62304 and other relevant standards
Establishment of validated document controls software to be used in design and development documentation in collaboration with software validation teams
Leading Design reviews to ensure that all required deliverables are met and documents are approved and properly referenced
Support Design Assurance team in structuring and maintaining all documentation related to the Design and Development of product for various Design projects including:
Phase deliverables and Design Review records
Design History File
Risk Management File in collaboration with the Risk Management team
Ensure project compliance to ISO 13485, ISO 14971, and U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 820.30 when appropriate
Provide guidance to teams for other development projects (Research Use Only, Investigational Use) when needed.
**Requirements**:
3-5 years of experience in the medical device / in vitro diagnostic industry with a focus on development & Design Controls.
Degree in quality, software, engineering, life sciences, and/or technical documentation.
Ability and willingness to learn/ use new software programmes. Experience with Veeva and/or Jira a plus.
A high attention to detail and ability to prioritise.
Will be a pro-active problem solver, working with projects to balance quality, cost, and timelines while remaining compliant.
Experience in auditing design and development processes and external certifications a plus.

**Benefits**:
Career opportunities in a fast-growing company with worldwide reputation
A flexible and friendly working environment with a collaborative atmosphere
Fantastic office locations in Switzerland
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

**Location**: Saint-Sulpice

**Starting date**: ASAP
If you think you fit this position, please send a CV and a cover letter.
As committed employer, SOPHiA GENETICS offers everyone the same opportunities to access employment regardless of gender, ethnicity, religion, sexual orientation, social status, disability or age. SOPHiA GENETICS strives to develop an inclusive work environment that reflects the diversity of its employees. All information will be treated confidentially in accordance with the Employment Equity Act.

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