Quality Assurance Specialist

4 days ago

Westmeath, Ireland beBeeQuality Full time €60,000 - €90,000

Job Title:

A Quality Assurance Professional is required to initiate and perform defined quality activities leading to new or improved processes or systems.

The role involves:

  • Initiating, reviewing, and approving change controls
  • Maintaining compliance for Product Manufacturing, Packaging, and Labeling
  • Developing a strategy and implementing appropriate sampling methods
  • Writing and reviewing CAPAs, NC/NCMRs, and SCARs to address compliance issues and providing guidance to suppliers and engineering teams
  • Performing Internal and Supplier Audits
  • Supporting and participating in external regulatory body audits, including ISO and FDA
  • Ensuring adherence to CGMP requirements and relevant associated documentation

Key Skills and Qualifications:

  • Degree-level qualification in Quality, Science, or Engineering is required
  • Minimum Three (3) years of experience working in regulated environments, specifically medical device, FDA, or ISO 13485 registered work environments is preferred
  • Medical device change control implementation experience
  • Strong computer skills (MS Excel, PowerPoint, Word)
  • Familiarity with statistical tools such as Pareto charts and trend charts
  • Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools
  • Experience with problem-solving techniques
  • Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates
  • Ability to work within a fast-paced team environment

About the Role:

  • Global medical Device company
  • Hybrid working model
  • Career advancement opportunities
  • Flexibility to work with different teams within other manufacturing units

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