Quality Engineer - Manufacturing

Job Description

The Quality Engineer- Manufacturing support will be the primary contact between Quality Assurance and Manufacturing. This person will provide expert QA support to Operations, in ensuring goals and objectives are achieved for the plant.

Roles/Responsibilities

• Provide effective and responsive QA support to Operations
  
• Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies.
  
• Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
  
• Drive and implement plant wide quality system improvements.
  
• Participate in the development and improvement of the manufacturing processes for existing and new products.
  
• Provide functional expertise to other support function on quality related issues.
  
• Interface with Suppliers for new processes, quality Issues and Process Improvements.
  
• Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
  
• Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
  
• Support site during External Audits. (i.e. FDA, IMB and BSI).

Skills/Experience

• Degree in Engineering, Science or equivalent is required.
  
• Minimum of 2 years experience in a QA role.
  
• Good level of technical and analytical skills.
  
• Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.
  
• Capable of working as part of a multi discipline team.
  
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
  
• High level of PC skills required.
  
• Excellent Communicator

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