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Expert Quality Assurance Professional

3 weeks ago

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

We are seeking a Quality Assurance Specialist on a permanent basis to join our team. This role offers the opportunity to work in teams of diverse and high-performing employees, tackling important health industry challenges.

Job Purpose:

To provide expert quality assurance support to operations, ensuring operational goals and objectives are achieved for the plant.

Key Responsibilities:
  • Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes (e.g., risk reduction, yield improvement, customer complaint reduction, error proofing, cost reduction initiatives, process automation activities).
  • Provide effective and responsive quality assurance support to operations to meet their area's objectives of quality, cost, and output.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
  • Drive and implement plant-wide quality system improvements.
  • Ensure regulatory compliance in area of responsibility to cGMPs of all medical device regulatory agencies.
  • Provide functional expertise to other support functions on quality-related issues.
  • Identification and implementation of appropriate statistical techniques to monitor process performance.
  • Approval of change requests for product, process, and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports, and analysis of complaint trends.
  • Validation: Define process, product, and test method validation requirements, preparation, and approval of Master Validation Plans, protocols, and reports approval.
  • Compilation of required regulatory documentation.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Support the implementation of lean manufacturing across the site.