Quality Engineer

Summary

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.


Full Description

Key Accountabilities:

  • 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)