applications

Leading Medical Devices Manufacturing Multinational looking for a Quality Engineer to join their growing team.

Roles/Responsibilities 

• Supervision of Quality Technicians and QC Inspectors.


• Drive and implement process improvements to ensure predictable processes across all product lines


• Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.


• Drive and implement plant wide quality system improvements.


• Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies


• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).


• Approval of change requests for product, process and quality system changes.


• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.


• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.


• Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements)


• Perform internal quality audits.


• Support the implementation of Lean Manufacturing across the site.


• Transfer and implement product and processes from development or from another manufacturing facility.

Skills/Experience

• Ideally will possess Bachelor of Science Degree in Engineering/Technology.


• 3/4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDAISO 9000 necessary.


• Excellent interpersonal and communication skills.

For more information on this role, please contact Gemma Nesdale in confidence on (021) 2300302 or email: gnesdale@brunel.ie