Quality Engineer – Medical Devices – with experience in a regulated industry required to join a leading Medical Device multinational based in Offaly. Working with a global team, the Quality Engineer with support quality engineering activities & compliance with global medical devices regulations.
- Working with a team, develop design verification & validation protocols for new and existing products & for product transfer
- Conduct detailed root cause analysis and define corrective and preventive actions
- Conduct Internal audits and supplier audits
- Develop inspection plans for incoming inspections
- Detailed review and approval of Risk Managements files
- Review and approval of change orders associated with components and manufacturing process
- Provide Operational QA Support for products and process
- Ensure quality manual & SOP’s are adhered to
- Review & Approval of Change Orders associated with components & manufacturing process
- BSc. in Engineering (Biomedical, Mechanical or Electrical)
- 3-5 years of experience in a Quality Engineering role in a regulated industry (medical devices or pharmaceutical manufacturing)
- Strong project management skills.
- Demonstrated knowledge of statistical sampling and analysis.
- Ability to work independently with minimal supervision.Accredited
- Lead/Biomedical Auditor certification strongly preferred.
- Knowledge of IEC 60601 electrical safety standards preferred.
- Lean/Six Sigma certification strongly preferred.
- Experience working in Oracle, Agile and TrackWise systems preferred
- Knowledge of FDA regulations, ISO standards, CMDR, MDD and others.
- Some travel is required.
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence