This Person will be working in the manufacturing area providing real time QA Engineering support to the problem solving. You will also be involved in the development of quality metrics and reporting systems and will be required to conduct process audits
- 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, prioritizing, communicating and resolving quality issues.
- Ensure regulatory compliance to GMP for all medical device regulatory agencies
- Suggest 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.
Min 4year industry experience in a medical device manufactuing.
Science/ Engineering/Quality Degree and relevant experience
Previous experience within the medical device industry in Quality / Engineering is essential as is demonstrated use of Quality tools/methodologies including Six Sigma techniques
Knowledge and Experience of Statistical Process Control would be beneficial
Excellent Computer Skills (word, excel, powerpoint and Access)
Excellent communication (both verbal and written) & interpersonal skills
Flexible, highly motivated individual and accountable
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