On behalf of a disruptive Med Tech company who are pioneering the way AI is used in the OperatingRoom, we are looking for a Senior Software Design QA Engineer to join the rapidly expanding QARA division.
The Quality Engineer will work on exciting projects, collaborating with the Software, and R&D teams to lead them through the new product development process, provide guidance on technical design, and implement strategies that drive product quality/continuous improvement. You will lead, direct, and organize Design Quality activities from Design Concept through Design Transfer.
Some key activities include:
· Participate in the development of requirements, software design, and software test design.
· Collaborate with cross-functional team to develop Software Failure Mode and Effects Analysis (SW FMEA) to drive robust design at early development stages.
· Propose changes in design to improve system and/or process reliability.
· Provide guidance for application of internal development procedures, including Design Control, Risk Management, Verification, and Software Development Lifecycle to the product development teams, within the framework of regulatory requirements (i.e. ISO13485, ISO14971, IEC62304).
· Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.
· Develop and maintain constructive working relationships with cross-functional team members, including Quality, Regulatory, R&D, Procurement, Marketing, and Operations.
· Bachelor of Science Degree in Biomedical, Mechanical, Electrical Engineering or other related fields
· Experience and working knowledge of standards applicable to Medical Device Safety/Risk Management (i.e. ISO13485, ISO14971, IEC 60601-1, US 21 CFR Part 820, etc.)
· Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
· Supplier Controls process knowledge and experience
· Strong interpersonal, organizational and project management skills
If this is a position that suits you, do not hesitate to apply now to learn more.
This company offer a very attractive benefits package and the role will fill quickly.
We look forward to receiving your application!