Senior Assurance Specialist

2 weeks ago

Limerick, Limerick, Ireland beBeeValidation Full time €75,000 - €91,000
Quality Assurance Professional

The Quality Assurance Professional plays a vital role in providing assurance and support to various teams within the organization.

Key Responsibilities:
  • Review and understand validation documentation, change requests, design and process FMEA's, test summaries, software validation, microbiological assessments, and critical system work orders.
  • Provide assurance and support to research and development and sustaining engineering departments, including transfer to production, ensuring design assurance activities are reviewed and associated documents are updated.
  • Support supplier appraisal and approval processes.
  • Liaise with production and quality control by providing assurance and support to incoming quality control, in-process, and final quality control.
  • Contribute to the corrective and preventive action program (CAPAs) and non-conforming product process.
  • Support internal audit, supplier audit, and regulatory audit programs.
  • Investigate and document complaints, assessing risk and implementing corrective actions.
Requirements:
  • Third-level qualification in science, engineering, or a relevant technical discipline.
  • Qualification in quality/validation/statistics/risk would be advantageous.
  • Proven knowledge and experience of working with ISO 13485, ISO 14971, medical device directive, EU medical device regulation, FDA QSR, and related standards.
  • Experience with all aspects of validation, including design, process validation, and software validation.
  • Good working knowledge of statistics and strong interpersonal skills.
  • Ability to challenge thinking and ensure adherence to quality systems and processes.

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