Senior Quality Engineer

* 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 the all products and materials are stored in conditions which meet the manufacturers requirement at all times.
* Actively participate in 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.
* Participates in and assist with facility inspections, Notified Body Audits and other audits as required.
* Identify new improvement opportunities.
* Other duties as assigned.
* In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

VORAUSSETZUNGEN:

* Higher level Degree qualification in Engineering/ Quality/ Science.
* Minimum 5 years experience working in a quality role within a manufacturing plant.
* Experience writing procedures in compliance with GMP.
* Working in an FDA regulated environment.
* Ideally, experience with SAP.
* Good working knowledge of Lean manufacturing (Black Belt Preferred)
* Experience in root cause analysis techniques and CAPA.
* Experience of labelling and traceability in a regulated environment.