Responsibilities & Qualifications:
- 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)
- 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