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A Senior Quality Professional

3 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time
Job Title

Our company is hiring a Quality Assurance Specialist for an initial 12-month contract. The role is offering a hybrid-based position with opportunities for career advancement.

As a Quality Assurance Specialist, you will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems. You will ensure compliance is maintained for product manufacturing, packaging, and labeling.

Key Responsibilities:

  • Initiating, reviewing, and approving change controls
  • Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling.
  • Developing a strategy and implementing appropriate sampling methods
  • Writing up and reviewing of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.
  • Performing Internal and Supplier Audits.
  • Supporting and participating in external regulatory body audits, e.g., ISO and FDA
  • Complying with all relevant training required and adhering to relevant associated documentation.
  • Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Following strict adherence to the requirements of CGMP.

Requirements:

  • Degree level qualification in Quality, Science or Engineering is required
  • Minimum Three (3) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
  • Medical device change control implementation
  • Strong computer skills (MS Excel, PowerPoint, Word etc.)
  • 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

What We Offer:

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

For further information, please contact us directly.