I am currently recruiting for an experienced Quality Engineer for one of the world's leading medical companies. The role is based in the Plymouth area, working within a permanent role offering a competitive salary.
Reporting to a Quality Leader, the Quality Engineer is responsible for monitoring all the operational aspects of the quality system and where appropriate, using relevant quality tools to support business activities to improve the operational effectiveness of the quality system.
- Use six sigma continuous improvement techniques to implement suitable corrective / preventive actions to reduce quality issues.
- Communicate with and co-ordinate the activities of the relevant departments to ensure compliance with documented specifications and procedures within the quality system.
- Support both operations and engineering departments in cross-functional teams.
- Develop and issue control plans, quality documentation and visual aids.
- Provide training and development for SPC on production processes
- Support cross-functional activities in the execution of Validations.
- Provide quality engineering support for internal audits, third party regulatory audits and customer complaints as required.
- Provide statistical advice for process investigation.
- Actively support / lead the development and maintenance of BD's quality systems (SAP / SFOL / QDMS).
- Ensure the detail and content of Quality Notifications / MRB decisions conform to the relevant procedural documentation.
- Audit / authorise release of the Document History Records for each production batch.
- Provide the development, mentorship and training for the Quality Inspection Teams.
- Maintain and develop the BOS Quality performance documentation as required.
- Experience in a quality role within a high volume medical device-manufacturing controlled environment.
- Knowledge of Six Sigma and Lean Manufacturing principles.
- Educated to either Degree / HND / CQI Diploma level.
- Evidence of continued professional development.
- Advanced knowledge of MS Office and Minitab
If you have the experience and skill set to match the requirements listed above, enjoy working in a collaborative and engaging culture and are driven by the challenge of assisting in developing innovative solutions for global issues then we are very interested in speaking with you.
Please be advised that due to the expected high volume of applicants we may be unable to reply to everyone individually.