ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
- Support manufacturing areas to achieve targets.
- Implement corrective action on issues as they arise.
- Disposition NC’s, conduct & determine root cause analysis including corrective actions.
- Conduct area GMP/GDP audits and follow up on findings to ensure satisfactory closure.
- Follow up on corrective actions for in-process and customer complaint issues.
- In-process sampling and testing and subsequent report writing.
- Conduct First Article Inspections on product as required.
- Conduct process audits against Quality System requirements.
- Support all QA related documentation activities (i.e. Raise Change plans, write procedures etc)
- Support functional area validation activities.
- Support fault analysis and scrap reduction activities.
- Participate/drive quality improvement projects/activities.
- Participate in preparing & on-going maintenance of FMEAs and control plans.
- Reporting function Quality metrics.
- Have a basic knowledge of ISO/FDA/MDD and other product development related regulatory requirements
- Have an understanding of standard metrology good practice.
- Provide support for internal and external audits to ISO and FDA requirements.
- Support prototype/manufacturing Operations area projects and initiatives i.e. Kaizen, CFPS etc.
- Other tasks as directed by the functional area Quality Technician / Engineer in line with company goals and objectives.
- Ensure all recording and cleaning logs are reviewed and approved per schedule
- Work closely with all BE department to support completion of validation and process development projects
- Carrying out investigations on product failures and customer complaints, reporting Non-Conformities and Out of Spec Results to the Quality Control Manager and Production Manager.
- Third level qualification in Science, Engineering or equivalent.
- Working knowledge of cGMP and ISO standards relevant to Quality Control procedures, documentation and testing.
- One year previous quality experience in a similar work environment is essential.
For More information please call Sean on 0879221136 or email your CV to [email protected]