Quality Associate

Vor 5 Tagen


Rolle, Schweiz SOPHiA GENETICS Vollzeit

We believe there is a smarter, more data-driven way to make decisions in health_. As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Quality Intern who will be be part of a dynamic and exciting international team. Our SaaS DATA Platform combines deep expertise in life sciences and medical disciplines with mathematical capabilities in data computing.

Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximizing the power of Data-Driven Medicine. SOPHiA GENETICS (NASDAQ: SOPH) combines collective intelligence in Genomics, Radiomics, clinical research data, the DDM - Data-Driven Medicine, we can ensure that the data used to help patients today will also benefit the patients of tomorrow.

Be part of our mission to disrupt the traditional healthcare model and democratize data driven medicine SOPHiA GENETICS is looking for a talented **Quality Associate** to join the Quality Assurance and Regulatory Affairs (QA&RA) teams at our headquarters in **Rolle, Switzerland.**

**Main responsabilities**
***:

- In charge of the non conformity (NC) process : provide support and ensure proper assessment of the NC within the company.
- Report relevant data and metrics regarding the performance of the non conformity process.
- Provide guidance on the NC process and display best practices accross the company.
- Support and help teams connecting with quality processes such as complaints, NC, CAPA and Change.
- Provide assistance in the event of recall and adverse event to the Regulatory department.
- Support and help during external audit and inspection: participation during the audit preparation, in the audit conduction and in the audit follow up.

**Requirements**:

- 2-4 years of experience in Quality Assurance
- Strong knowledge in ISO13485 and FDA QSR
- Master in scientific field (preferably in Biology, Biotech, Bioinformatics)
- 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.
- Fluent in **English and French** is a must.

**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, Switzerland. Office-based, including 2 days per week remote / 3 days on-site.

**Start**: ASAP (or as agreed)

**Contract type**: Permanent, full-time

**Application process**:



  • Rolle, Schweiz SOPHiA GENETICS Vollzeit

    We believe there is a smarter, more data-driven way to make decisions in health_. As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Quality Intern who will be be part of a dynamic and exciting international team. Our SaaS DATA Platform combines deep expertise in life sciences and medical...