Type: FTC, occasional travel to the Southern site (expenses provided)
Duration: 12 months (could be extended or potentially lead to a permanent role)
Salary: Competitive DOE
This position reports into the Manufacturing Quality Manager
Our Client, a Global Medical Devices company are looking to appoint an experienced QE to be involved in a large product and process equipment transfer project.
- Liaise with Relevant Departments on the completion of risk assessment, Work Instructions, Validations and FMEA's for both new product introductions and existing product line changes/process improvements.
- Contribute to, review and/or develop and execute facility, software, process and equipment validations and risk management documents
- Review change controls for process/design impact.
- Knowledge of statistics to assist with validation developments and process improvements
- Provide quality support to relevant departments with sampling plans, data processing or analysis for validation for new and existing product lines.
- Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
- Complete CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
- Perform Internal Audits/Supplier Audits.
- Assist in the development, analysis and improvement of site Quality Metrics.
- Lead/Support project activity in your area of responsibility
- Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of cGMP.
- Liaise/support with suppliers to ensure drawings and specifications are clear, understood and fully compliant.
- Will hold a Degree in a relevant / Scientific discipline or a Degree in Engineering
- Experience of working within a Quality environment within the Medical Devices / Pharma Industry in a QE related position with extended experience in change controls and validation