RAQA Engineer

A Little Bit about Us

VarSome.com is the world’s leading website for professional human genetics. With more than 4 000 citations in scientific papers, 60 000 registered professional users, we are seeking to bring together all the human expertise in molecular genetics. VarSome Clinical is a comprehensive decision support software platform for genetic testing.

VarSome is created by Saphetor, a Switzerland-based precision medicine company with offices in Lausanne, Boston, and Athens, using bioinformatics to apply human genome data to improve health and lives worldwide. 

Saphetor is pioneering the use of big-data sequencing technology, such as exome and whole-genome sequencing, for clinical practice. We are involved in both clinical research and diagnostics, providing our clients with quality analysis and interpretation of next-generation DNA sequencing (NGS) data. All our services are provided over the web, and our VarSome.com website is the world’s prime reference for genetic variant interpretation.

The Opportunity

We are on the lookout for RAQA Engineer, reporting directly to the RAQA Director, who will have the following areas of responsibility. 

Role Responsibilities

-Quality Management System

• Participate in the maintenance and improvement of the Quality Management Systems (ISO 13485 & ISO 27001)
• Provide support for organizing Management Reviews (collection of quality metrics from process leads, analyse data, prepare reports)
• Manage the post-market activities (CAPA process, change control, complaints)
• Support the company computerized system validation.

-Device Development Quality

• Represent the Quality team member in the development team
• Review the change requests 
• Participate to the risk management
• Review and approve all the requirements and documents related to the medical device development
• Support all stages of the software product development process

-Regulatory Affairs

• Provide support to constitute the IVDR technical file.
• Develop internal awareness on regulatory aspects typically through company-wide training on data protection, IVDR, FDA, ISO, etc.  requirements.
  

-Represent the Person Responsible for Regulatory Compliance (PRRC) for Saphetor SA, as defined in IVDR art. 15

• Ensure the conformity of the devices is appropriately checked, in accordance with the Saphetor's ISO QMS before a device is released;
• Ensures the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.;
• Ensures the implementation of a post-market surveillance system compliant with IVDR Art. 78 is done;
• Ensures the reporting obligations referred to Vigilance described in IVDR art. 82 to 86 are fulfilled
• Ensures, in case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.

What you will bring:

• BS or MS degree in Engineering or Computer Science or scientific degree in Life Sciences
• Education on Quality Management System
• Relevant RAQA experience; demonstrated proficiency with the Quality Management
• System related to software medical devices or in vitro diagnostic software medical devices.
• Knowledge of ISO 13485, IEC 62304 , ISO 14971 & IVDR 2017/746
• Experience in the medical device software development process in agile mode
• Ability to learn about genetics will be critical to the success of this role and enable to better understand the cutting-edge medical services we offer
• Good understanding of cybersecurity requirements
• Problem-solving and project management abilities
• Strong knowledge of the English language written and verbal

Your career journey with us includes, among others:

• A position in a fascinating healthcare growth domain, at the cutting edge of technology and research.
• A competitive compensation package 
• Remote work interaction with global teams on a regular basis. Everyone in the company speaks fluent English and the company is well-experienced in coordinating a regionally distributed team, using an agile work-flow.
• Endless learning opportunities, while transferring new technologies from academics to clinical practice all over the world.

Saphetor is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and our employees, regardless of race, color, religion, national origin, age, sex, medical condition or disability, sexual orientation, gender expression, or marital status.