Quality System Engineer with strong working knowledge of ISO13485 and FDA QSR requirements required for critical role with medical devices multinational in Galway
Key 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
- Coordinate and manage all external audits
- Manage the site internal audit process
- Manage the site internal CAPA process
- Approvals as defined on Oracle
- Identify deficiencies in quality systems and defines systematic corrective actions
- Develop effective quality metrics and communicate the results to key stakeholders using reports, presentations, and dashboards
- Ensure compliance and drive improvements in QS processes
- Assist in the preparation and maintenance of records associated with the management review process
- Participate 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)
- Level 8 Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance
- 3-5 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
- Passionate about Regulatory compliance
- Experience with internal & external audits
- Experience working with an Enterprise Quality Management Software system (such as SmartSolve)
- Ability to work under pressure
- 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
- Must already be eligible to work in Ireland (sponsorship not provided)
