Quality Associate (Design Control Lead)

SOPHiA GENETICS

Lausanne, CH
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 12/21/2020
  • Website: sophiagenetics.com
  • Company Address: 185 Dartmouth Street, Suite 502, Boston, MA, 02116

About SOPHiA GENETICS

SOPHiA GENETICS 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. We achieve this mission through the global adoption of SOPHiA AI, which is built using techniques such as statistical inference, pattern recognition and machine learning. This enables SOPHiA to provide equal benefits to all users, unite experts in a gold standard health tech platform, and motivate expert knowledge sharing for a sustainable impact on future patients.

Job Description

SOPHiA is looking for a highly organized Team Member to work in the Quality Department, focused on helping design teams be compliant with design control 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 flexible with a sense of urgency, and display personal characteristics that emulate our Company Core Values of Teamwork, Integrity, Accountability and Adaptability. Candidates should also have a genuine interest in Quality as a career.

The Design Control Lead 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:

    Assist design teams to draft process and documentation for gathering requirements and testing for products to meet design control requirements per FDA QSR and ISO 13485/IVDR/MDR
    Manage all documentation related to the Design and Development of product for various Design projects.
    Coordinate meetings to ensure design reviews are conducted
    Ensure appropriate documentation is finalized at various design phases and signatures are obtained
    Compile Design History File and ensure DHF is updated as necessary when changes are made
    Facilitate requirements gathering sessions to identify user needs and translate needs to engineering requirements
    Coordinated with supplier partner to finalize design and confirm requirements
    Direct teams through project and product life cycle Design Controls to ensure documentation is complete
    Facilitate product assessments to identify potential product risks, risk impact, and risk mitigation
    Ensure project compliance to ISO 13485, ISO 14971, and U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 820.30.
    Participate on international project teams to develop medical device products for global launch

Requirements

    3-5 years of experience in the medical device industry
    Ability to perform word processing and create basic spreadsheets, as well as work in Adobe and numerous on-line media
    Ability and willingness to learn/ use new software programmes
    A high attention to detail and orderly focus

    Background in editing or documentation management

    Will be a pro-active problem solver

    Work to maintain efficiency and quality balance in your work

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.

Please note that incomplete applications will not be considered.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.