SOPHiA GENETICS S

Quality Associate (Design Assurance Engineer) (BB-20A2E)

Gefunden in: Xpatjobs CH

Beschreibung:

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 Assurance Engineers represent the Quality Department in the product development teams, ensuring that all activities, including completion of deliverables as per our internal SOPs and reviews are conducted in a timely manner. They assist the Quality Design Controls Lead in maintaining design documentation for Design History Files to meet Design Control requirements as required per FDA QSR and ISO 13485/IVDR/MDR.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Participate on international project teams to develop medical device products for global launch
  • Assist the Project Management Office in project governance to ensure that Quality stage gates are met during product development
  • Direct teams through project and product life cycle Design Controls to ensure documentation is complete per FDA QSR and ISO 13485/IVDR/MDR
  • Facilitate requirements gathering sessions to identify user needs and translate needs to engineering requirements
  • Coordinate meetings to ensure design reviews are conducted
  • Ensure appropriate documentation is completed at various design phases and signatures are obtained
  • Draft product development plans with design, development and validation teams, and business stakeholders, to facilitate project planning and product launch
  • Provide guidance to project teams to ensure applicable labelling requirements are met in collaboration with the Regulatory team
  • Coordinate with Knowledge Management and the Design Controls Lead to maintain product Design History Files and ensure the DHF is updated as necessary when changes are made
  • Facilitate product assessments to identify potential product risks, risk impact, and risk mitigation in adherence to ISO 14971
  • Requirements

  • At least 2 years of experience in the medical device industry
  • Engineering degree preferred
  • 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; experience with electronic quality management systems and documentation systems a plus
  • 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
  • Efficient remote work environment during coronavirus crisis
  • 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
  • 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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    location_on Lausanne , Vaud, Schweiz

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