My client a world leader in medical precision components and assemblies is seeking a quality engineer to direct all site validation activities and compliance.
·Work closely with all departments on quality related matters such as process control, improvement practices, and to ensure customer and business requirements are met in a timely fashion.
·Internal audits, and participate in external and third party audits.
·Provide technical expertise and knowledge on process validation.
·Be responsible for creating and maintaining Validation Master Plans and documentation.
·Create and put into action Validation documents / protocols for new process & equipment (DQ, IQ, OQ, PQ, PPQ)
·Assist with the creation of URS's.
·Create Work Instructions & SOP's.
·Maintain & promote GMP.
·Ensure compliance to and maintenance of ISO 13485:2016.
·Manage the CAPA process.
Education/Qualification - Minimum:
·ISO 13485:2016 internal auditor certification preferred.
·HNC or equivalent
·Medical experience in a production / manufacturing environment
·Good working knowledge of ISO 13485:2016 QMS.
·Validation experience an advantage
·Good customer facing skills.
·Attention to detail.
·Good organizational skills
·Ability to manage multiple projects simultaneously.
If you feel you have the experience and wish to discuss the role in more detail please contact Harrison Smith at firstname.lastname@example.org