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Senior Quality Professional

3 weeks ago

Waterford, Waterford, Ireland beBeeQuality Full time €65,000 - €85,000
Job Title:

NPI Quality Engineer

Key Role Summary:

This quality professional will play a pivotal part in the development and implementation of quality plans, programs, and procedures utilizing quality control statistics, lean manufacturing principles, and analysis techniques.

Core Responsibilities:
  • Provide technical support throughout the new product introduction (NPI) process to ensure compliance with relevant FDA, QSR, MDR & EU GMP standards/guidelines.
  • Apply quality engineering tools and methods with emphasis on validation protocols (DQ, IQ, OQ, & PQ), current Good Manufacturing Practices (cGMP), Failure Mode and Effects Analysis (FMEA), and assist in generating regulatory documents as needed.
  • Facilitate the transfer of ownership from NPI to production phase, collaborating with cross-functional teams and operational workcells.
  • Prioritize projects based on business needs and requirements.
Required Skills and Qualifications:
  • Bachelor's degree in a life science or related field.
  • 2-4 years of experience in manufacturing, preferably within the medical device/pharmaceutical industry.
  • Strong organizational and planning skills are necessary to plan, execute, and track quality commitments.
  • Familiarity with ISO 13485 and/or EU GMP regulations is highly desirable.