Senior Quality Engineer (m/f)

Currently we are looking for a Senior Quality Engineer (m/f) for an interesting project.

+ Develop procedures for the correct Identification and Labelling of product throughout all stages of the process, including Goods, In, Production, Distribution Warehouse and Customer Returns.
+ Develop procedures to ensure that all products and materials are stored in conditions which meet the manufacturers requirement at all times.
+ Evaluation of regulatory compliance of labelling procedures, and processes and where necessary recommend appropriate improvements to the process.
+ Organise the preparation of files suitable for FDA audit
+ Participate in and lead internal audits.
+ Participate in and assist with facility inspections, Notified Body Audits and other audits as required.
+ Identify new improvement opportunities.

+ Higher level Degree/ Level 8 qualification in Engineering/ Quality/Science.
+ Minimum 5 years’ experience working in a quality role within a manufacturing plant, preferably in the medical technology industry.
+ Experience in writing procedures in compliance with cGMP.
+ Working in an FDA regulated environment.
+ Ideally, experience with SAP.
+ Good working knowledge of Lean manufacturing
+ Experience in root cause analysis techniques and CAPA.
+ Experience of labelling and traceability in a regulated environment.

If you are interested we are looking forward to receiving your profile with your rate per hour.