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.
