Collins McNicholas

Responsibilities & Qualifications:

Job Responsibilities:

  • Actively stays current with external and internal quality system standards and requirements.
  • Providing Quality Systems support for the Galway site.
  • Support QMS integration activity across the Galway site.
  • Responsible for coordinating and managing all external audits.
  • Responsible for managing the site internal audit process.
  • Responsible for managing the site internal CAPA process.
  • Approvals as defined on Oracle.
  • Identifies deficiencies in quality systems and defines systematic corrective actions.
  • Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards.
  • Ensure compliance and drive improvements in QS processes.
  • Assists in the preparation and maintenance of records associated with the management review process.
  • Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned.
  • Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis)

Key Requirements:

  • Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance.
  • A minimum of 2 years experience as a Quality Engineer within the Medical Devices or Pharmaceutical industry.
  • Strong working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.
  • Regulatory experience / knowledge.
  • Excellent communication and inter-personal skills.
  • Proven ability to influence.
  • Excellent attention to detail and report writing skills.
  • Highly organized with strong ability to prioritize tasks and work on own initiative.
  • Trained Auditor ideally lead auditor training and/or experience

 

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