Senior Quality Engineer Location: Galway, Mayo, Clare Salary: 55 000K - 60 000K


 

Senior Quality Engineer

This company is a leading innovator in the development of medical device products in the West of Ireland. Due to expansion within the company, an exciting opportunity has arisen for a Senior Quality Engineer.

The Senior Quality Engineer will:

• Perform an active role in quality planning and new product introduction.
• Develop and maintain documentation to QSR and ISO requirements.
• Prepare Product and Process Validation Protocols and Reports.
• Perform Internal and Supplier Audits to ISO and FDA requirements. Play an active role in the preparation and execution of audits by external parties.
• Establish inspection standards, plans, frequencies and test methods.
• Provide written and verbal direction in the documentation and investigation of returns and complaints.
• Make appropriate decisions on a daily basis, using the Quality Assurance Manager as the final arbitrator on critical quality decisions.
• Champion continuous improvement and innovation from a quality perspective.
• Responsible for the collection of  key process indicator data, and the preparation of this data for monthly and six monthly management reviews.
• Ensure all areas handling material are complying to documented procedures, and liaise with QA manager and relevant departmental managers to ensure non conformances are identified and addressed.

Requirements:

• Successful candidate must have 5+ years experience in a quality role in the medical device industry.
• Candidate must be degree qualified.
• Must be familiar with FDA GMP/QSR; ISO 13485 and medical standars.
• Experience in Sterilisation and Microbiology is advantageous.

For immediate consideration for this role please apply online or contact:

Shane Browne - (01) 632 1865
HRM Science Selection Team

YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE

Specialists in
[Scientific Jobs] [Pharmaceutical Jobs] [Biotechnology Jobs] [Laboratory Jobs] [Chemistry Jobs] [Quality Jobs] [Clinical Jobs] [Graduate Jobs] [Medical Jobs] [Food Jobs] [Medical Device Jobs] [Pharmacy Jobs] [Clinical Research Jobs] [Nursing Jobs] [Dublin Jobs] [Irish Jobs] [Science Jobs] [Engineering Jobs] [Radiography Jobs] [Regulatory Affairs Jobs] [Analytical Jobs] [Microbiology Jobs]

We Always Want to Hear From
[Consultants] [Laboratory Technicians] [Lab Analysts] [Health & Safety Officers][Scientists] [Medical Scientists] [Quality Control Analysts] [Quality Assurance Analysts] [Doctors] [Chemists] [Analytical Chemists] [Pharmacologists] [Biochemists] [Microbiologists] [Quality Managers] [Radiographers] [Quality Engineers] [Qualified Persons] [Pharmacists] and all other scientific and medical professionals...

We Can Offer You
[Expert Advice] [Interview Tips, Techniques & Strategy] [Salary & Benefits Advice] [Career Counselling]
[A Smooth Straightforward Recruitment Process from Start-to-Finish]