- Qualification and Validation of equipment and processes (IQ, OQ, PQ, writing and performing.
- Quality controls for technical release, ensuring product compliance
- QMS Activities - Responsible for documentation of activity within the quality team
- 3-5 years of experience in Quality Assurance or Quality Control within the Medical Device (MDR) or Diagnostics (IVDD/IVDR) industry.
- Direct working knowledge of Computerised Systems Validation is essential
- Strong knowledge of quality standards and regulations, including ISO 13485.
- Experience with software applications such as Veeva and Jira is a plus
- Fluency in English essenial, additional languages such as French is a plus
- 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
- 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
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Quality Specialist - Rolle, Schweiz - SOPHiA GENETICS
Beschreibung
Do you want to be part of a company that is revolutionizing healthcare through data-driven medicine? SOPHiA GENETICS, a global leader in data-driven medicine, is seeking a talented Quality Specialist to join our team.
Why us:
We believe there is a smarter, more data-driven way to make decisions in healthcare and our AI SaaS Platform enables that. You will have direct input into our mission to radically improve the outcomes for Cancer & Rare Disease patients globally. Enable our customers to push industry boundaries, as we pioneer into newly discovered fields and combine complex, multi-modal data for the first time
The Value you add:
As a Quality Specialist at SOPHiA GENETICS, your primary responsibility will be to manage our Computerised Systems Validation, whilst also ensuring the quality and compliance in our products and processes.
Requirements
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:
Plus, you will find :
Location: Rolle, Switzerland. Hybrid Office-based (3 days on-site.)
Start: ASAP (or as agreed)
Contract type: Permanent, full-time
The Process
Apply now with your CV and any supporting information. As a global organisation, English is our business language and English-only speakers will be involved in your hiring process. Profiles should be in English for a successful review.
Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader, alongside key colleagues and stakeholders from across the business.
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