About Our Quality Engineer Role
This position ensures the quality and risk management aspects of new product development projects.
* Representing quality interests on project teams
* Ledning risk management activities and owning quality engineering tasks for NPD projects
* Review design control compliance requirements for NPD projects and all design elements
Main Responsibilities:
* Leading quality engineering activities and performing risk management tasks
for NPD projects,
* Determining whether new products meet design control compliance requirements
* Developing UFMEA & DFMEA, coordinating guidance from design sub-team members
About You:
* A third-level engineer or technical/science qualification is required
* Minimum of five years in the medical device or pharmaceutical industry desired
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
* Excellent interpersonal skills with ability to work in a team environment and under own initiative to target deadlines
* Attention to detail and adaptability