Quality Engineer, Medical Devices
Location: North Yorkshire
Type: Fixed Term Contract for 18 months
Salary: Competitive DOE
Additional: Upto 5% bonus, Pension - EE 3%, ER 6% or EE 4%, ER 8%, 4x annual salary life assurance
Cont… BUPA private medical care, canteen, and gym onsite
Hours: Monday - Thursday (8.30 - 16:30), Friday (8:30 - 13:30)
Our Client, an established/global medical device company currently experiencing major growth; is looking to recruit for an experienced Quality Engineer who will work at their modern site in North Yorkshire.
This position reports into the Quality Engineering Manager
- 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 NC and 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.
- Experience of working within a Quality environment within the Medical Devices / Pharma Industry.
- Will have experience in CAPA, auditing, validation and risk management in a QA/ QE setting ideally (not QC/ Analytical Lab setting).
- A Degree in Engineering or Science is beneficial as the role includes review of analytical data.
- They will have the ability to perceive and drive forward improvement in the manufacturing areas in regards to Quality.