Quality System Engineer with strong working knowledge of ISO13485 and FDA QSR requirements required by medical devices multinational in Galway for 12 month fixed term contract.
- Actively stays current with external and internal quality system standards.
- Providing Quality Systems support for site.
- Support QMS integration activity across the 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.
- Ensure compliance and drive improvements in QS processes.
- Assists in the preparation and maintenance of records.
- Completed monthly Manufacturing Training Report.
- BSc. in Quality Assurance or Science/Engineering
- 3-5 years’ experience as a Quality Engineer within the Medical Devices/Pharmaceutical industry
- Strong working knowledge of ISO13485 and FDA QSR requirements
- Regulatory experience / knowledge
- Proven ability to influence
- Excellent attention to detail and report writing skills
- Trained Auditor ideally lead auditor training and/or experience
Please contact Emer Moore to discuss in confidence