Description
Would you like to join a World Leader in the Medical Device Industry?Do you have experience in a Quality role in the Medical Device sector or another regulated industry?
If so then this could be the opportunity for you.
Role:
Perform quality systems work requiring full competency in all conventional aspects of quality systems in regards to the processes and products relating to disposable,sterile and non/sterile products manufactured within a sterile clean room environment.
In particular processes supporting complaint handling,supplier management,internal & external quality audits,CAPA,component compliance and QMS training.
Plan and conduct work requiring judgement in the independent evaluation,selection and the substantial adaptation of standard quality system techniques,procedures and criteria
Key role in ensuring product issues are promptly investigated and adequate corrective/preventive action implemented e.g out of specification components,etc Ensure all Quality System procedures are established under one system that implements the requirements of the FDA QSR, ISO 9001, ISO 13485, Medical Device Directive.
Ensures the CAPA,internal quality audit and supplier management systems are operating effectively and close out of corrective actions meets expected deadlines. Supports Material Review Board activities from a quality perspective to ensure timely disposition of materials.
Co-ordinates RAQA presentations ensuring that meeting materials are available in a timely manner. Encourages data driven performance and achievements of quality objectives
Experience Required:
Degree Qualified or equivalent
Proven direct experience in a Medical Device industry or regulated company within a Quality Systems role
Experience in GMP and ISO quality systems standards. ISO 9001, iso 13485 assessor would be very desirable.
The role is based in Lancashire and paying up to 38k
To find out more about Huxley Associates please visit www.huxley.com