QUALITY & VALIDATIONS ENGINEER
Location: London Road, Derby Salary: £27,000 - £31,000
Full time, permanent Mon - Thurs 08:30 - 5pm, Friday 3pm finish
Responsible for the implementation, development and continual compliance of the Quality Management System throughout the company, with particular attention for leading and managing the validation of processes and products.
- Design or plan validation protocols and other documentation for equipment, processes or products meeting internal and external safety and quality requirements.
- Conduct validation or qualification tests for new or existing processes, equipment or products.
- Lead and provide an analysis of data by using software such as Minitab or similar on the results of test data to show the necessary quality performance stability requirements have been met.
- Managing the sites Validation Master Plan and Calibration Master Plan.
- Perform product testing in the laboratory which includes determining appropriate test methods, housekeeping, maintenance of test equipment and well as testing and monitoring protocols and recordkeeping as required.
- Review and revise specifications for products and processes, including creating drawings in Easy Cad software.
- Supporting the Quality Manager with ensuring that the quality management system as defined in ISO 13485 is implemented and maintained.
- Write or review Standard Operating Procedures or Work Instructions and other quality documentation as necessary.
- Provide a lead in problem solving, supplying targets for yield improvements, conducting failure and root cause analysis including risk assessments and FMEA activities.
- Support the management, investigation and analysis of Supplier and Customer quality complaints
- Support robust & timely audit activities across the Company, including procedural, process and product audits & that necessary corrective measures are put in place; includes hygiene audits.
- Support New Product Development processes, including labelling, specifications, customer requirements
Education / Qualifications
- Degree in Bio-medical Engineering, Science, Mechanical Engineering or Manufacturing.
- Thorough knowledge of validation processes for machinery and products as per ISO 13485 and other ISO or international standards
- 2+ years in Quality department role
- ISO 13485 implementation experience
- Quality control/assurance background
- Manufacturing industry experience
- Technically astute, interpreting technical drawings
- LEAN manufacturing experiencePreferable
- Project management skills
- Good interpretation skills of data using statistics
- Experience in plastics processing
- Quality auditing experience
- Experience driving positive change, leading and implementing improvements
- Biomedical Engineering
- Quality Control
- ISO 13485
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