
Quality Assurance Specialist
5 days ago
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
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