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- Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
- Direct involvement in operations area projects and initiatives (i.e. Six Sigma improvements, Lean, etc.).
- Develop and implement quality metrics and reporting systems.
- Preparation of Quality reports for Quality meetings and management reviews.
- Take a lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective team member in supporting quality disciplines, decisions and practices.
- Apply sound, systematic problem solving methodologies in identifying, prioritising, communicating and resolving quality issues.
- Ensure regulatory compliance to GMP for all medical device regulatory agencies.
- Suggests changes in procedures and standards to facilitate work efficiency and maintain quality.
- Reporting functional area Quality Metrics.
- Perform an active role in quality planning and new product/process introduction.
- Conduct internal quality audits to ISO and GMP requirements.
Skills Experience & Qualifications:
- Minimum 4 years industry experience in Quality/Engineering in a medical device manufacturing.
- Science/Engineering/Quality Degree and relevant experience.
- Demonstrated use of Quality tools/methodologies including Six Sigma techniques.
- Knowledge and experience of Statistical Process Control would be beneficial.
- Excellent computer skills.
- Excellent communication skills (both verbal and written) and interpersonal skills.
- Flexible, highly motivated individual and accountable.
For a confidential discussion on this role please contact Edel Kelly on 091-706713 or email firstname.lastname@example.org
For further information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie