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  • DUBLIN 2
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  • Job reference number:15330022
  • Client ID:RI/RS 16144
  • Posted on:07-MAR-2018
  • Location:OFFALY
  • Job type:PERMANENT

Quality Engineer (medical device) - Co. Offaly.

Reporting to the Quality Manager, you will be responsible for initiating, recommending, verifying and providing solutions to prevent the occurrence of any non-conformity related to the product, process and the quality systems.

Key Responsibilities:

• Investigation of production issues, containment & analysis.
• Customer complaint evaluation, analysis, reporting and timely closure.
• Complaint trending and monitoring of corrective actions.
• Control of Non-Conforming Material Review.
• Maintenance & communication of GMP standards throughout the plant.
• Development, issuance and implementation of QA documentation.
• Liaise with superior and other functional supervisors routinely.
• Participate in the development, validation and implementation of the manufacturing processes and equipment for existing and new products.
• Manage / execute site quality systems including CAPA, internal and supplier auditing, product release and validation activities.
• Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities within the team.
• Adherence to regulatory standards including ISO 9001, ISO 13485, FDA 21 CFR Part 820
• Delivering in-house training on quality assurance concepts and tools.

Essential requirements for this position:

3rd level Qualification in Quality / Science / Engineering with a minimum of 3-5 years' work experience in a Quality Assurance environment is required.
• Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products.
• Excellent communication skills – both written & verbal and interpersonal.
• Computer literate (e.g. Microsoft Word, Excel, Internet, Email).
• Self directed and results driven team player with excellent communication skills.


• Lean/Six Sigma Training an advantage.
• Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing.
• Candidates from a Medical Device background will have a distinct advantage.
• ISO 9001 and/or ISO 13485 knowledge.
• Internal Auditor Training
• Projects a strong professional image and able to interact within all levels of the organization.
• Lean Six Sigma Green Belt Certification or a willingness to gain such certification is desirable

This job originally appeared on RecruitIreland.com