A vacancy has now arisen for a Quality Engineer at Plymouth. The role will be responsible for technical documentation, project management and co-ordination of projects with other departments. Based in Plymouth, this role will report to the Quality Manager.
- Develop, generate and maintain documentation to support an effective and compliant Quality Management System including:
- Product and process FMEAs/risk assessments
- Customer complaints
- Medical device risk management reports and files
- Quality inspection procedures and control plans
- Material and product specifications
- Process flow chart
- Quality systems and process SOPs and work instructions
- To aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC.
- To accurately record data, calculate results and file information in accordance with AMS Quality Management System requirements
- To actively participate in the investigation of quality issues including; customer complaints, non-conforming material (NCMR), out of specification results (OOS), product failures, identifying effective corrective and preventative actions (CAPA), as required
- Progress and implement assigned actions to address non-conformities in a timely manner
- Maintain communication between departments (Quality, R&D and Production) on the status of projects and investigations
- Generate, update and maintain quality procedures, test methods and instructions
The ideal candidate will have:
- Bachelor of Science Degree in Engineering or associated field, or equivalent industry experience
- Experience in medical device industry / Knowledge of ISO13485 & FDA QSR requirements
- Working knowledge of Oracle and ERP System
- Ability to read, analyze and interpret technical procedures and governmental regulations.
- Ability to write technical reports, protocols and procedures.
- Knowledge of world class quality techniques and implementation
- Good working knowledge of validation, statistics and technical drawings
- Knowledge of good manufacturing practice, good laboratory practice and quality systems
- Strong attention to detail
- Good organisational and communication skills
- Ability to identify and implement continual improvement initiatives
- Ability to manage own time effectively, prioritise tasks and meet critical deadlines
- Ability to work autonomously and as part of a multi-disciplinary team
- Flexible and adaptable to changing working environment
- Good understanding of statistical data analysis (working knowledge of Minitab or other statistical tools preferred)