Senior Design Assurance Specialist

2 weeks ago

Enniscorthy, Loch Garman, Ireland beBeeQuality Full time €43,300 - €73,600
Job Overview

Our company is seeking a talented Design Quality Engineer II to lead quality and risk management activities throughout the lifecycle of new product development projects. This role involves ensuring that new products meet local, corporate, and divisional safety and efficacy requirements.

The ideal candidate will have strong problem-solving skills, attention to detail, and excellent interpersonal skills, with experience in managing multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.

">Main Responsibilities:
  • Represent quality interests on project teams.
  • Lead risk management activities and own quality engineering tasks for NPD projects.
  • Balance multiple projects and tasks from product inception through launch and maintenance.
  • Review design control compliance requirements for NPD projects and all design elements.
  • Develop UFMEA & DFMEA, coordinate guidance from other design sub-team members, and support PFMEA development.
  • Perform DOE's and statistical analysis to optimize products and processes or resolve causes of variation. Initiate corrective actions as required.
  • Support biocompatibility testing required by ISO10993 and company procedures.
  • Participate in internal audit and supplier audit programs.
  • Risk management – U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.
About You
  • Third-level Engineer / Technical / Science Qualification.
  • Minimum of 5 years in the medical device or pharmaceutical industry desirable.
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
  • Attention to detail and adaptability.
  • Dedication to excellence, flexibility.
  • Problem-solving techniques with excellent organization skills.
  • Excellent interpersonal skills with ability to work in a team environment and work under own initiative to target and deadlines.

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