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Stelfox Recruitment is one of Ireland?s premier recruitment companies, specialising in the recruiting of Engineering professionals for leading Multi National and Irish companies with a strong focus on the Pharmaceutical, Medical Device and Regulated Manufacturing Industries.

Quality Engineer ? Moulding

My client is Dublin based medical devices company; due to expansion they are currently seeking an experienced Quality Engineer to join their operation.

The Quality Engineers duties will include management of process improvement and validation activities while supporting manufacturing, specifically within moulding area.  

Responsibilities:

• Coordinating quality resources allocated to the Moulding department to ensure optimal efficiency and compliance with all regulatory requirements.
• Drive and maintain cGMP practice within the Moulding department.
• Preparation, review and approval of technical documentation.
• Ensure all Moulding related CAPA?s are completed in compliance with all regulatory and procedural commitments.
• Become an active member of the site internal audit team, liaising with Regulatory auditors.
• Devise and implement Six Sigma continuous improvement projects.
• Ensure Moulding support area operates in accordance with current best practice.
• Review, analyse and report on relevant customer complaints.
• To carry out Quality and Regulatory Compliance functions within the Quality Engineering Team.

Requirements

• Third level qualification in a Science / Engineering discipline.
• 5 years+ work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
• Knowledge of Statistical Process Control and Six Sigma methodologies
• Experience in CAPA system management
• A working knowledge of FDA requirements and managing FDA audits.
• Experience in moulding, process validation and working in a clean room environment.

Keywords: Quality Engineer, Engineering, Quality Systems, QA,, QC, Science, Process Control, Six Sigma, CAPA, Medical Device, Pharmaceutical, FDA, ISO, GMP, Moulding, Validation, Audit, Stelfox, Dublin, Leinster 

For more information on this and other suitable opportunities be sure to submit your CV NOW or Brian Mahon on 01 6793183. 

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