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Quality Engineer

Job Title: Quality Engineer
Contract Type: Temporary
Location: Limerick
REF: 84115
Job Published: over 2 years ago

Job Description

Quality Engineer

Our client, a leading medical device company requires an experienced Quality Engineer for a role in Limerick. This person will provide expert QA support to Operations, in ensuring plants and business unit goals and objectives are achieved.

Key Responsibilities:
  • Quality Improvements
  • Provide effective and responsive QA support to Operations to resolve in-house quality issues, and support the resolution of Customer and Supplier issues as required.
  • Drive and implement plant wide quality system improvements.
  • Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
  • Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
  • Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, Validations, NCR, Quality Awareness Tests.
  • Responsible for input to Quality Metrics.
  • 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.
  • Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
  • Has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. Also has the authority to order the recommencement of production provided he/she are satisfied that all issues pertaining to the non-conformance have been addressed.
  • Coordination of MRB activities to the business unit to ensure the timely assessment of potential non-conforming products.
  • Support pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
  • Evaluation of Customer Complaints (PER Investigation) as required.
  • Problem solving / Trouble shooting of customer complaint investigations, coordination of root cause and risk assessments.
  • Lead risk assessment activities and ensure that all failure modes in process have been identified and addressed.
  • Lead Problem Solving meetings using the following: 4D, DMAIC etc.
  • Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
  • QA review and approval of unplanned maintenance routines.
  • Support site during External Audits. (I.e. FDA, IMB and BSI) and Internal Audits as required.
  • Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, BSI etc.).
  • Ensure compliance of QMS procedures within the Business Unit.

Education, Experience and Skills;
  • Degree Engineering, Science or equivalent is required (NFQ level 8)
  • Minimum of 4 years? experience in a similar role.
  • Good level of technical and analytical skills.
  • Working knowledge of statistical techniques, green /black belt six sigma.
  • 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 and excellent communicator.

For further information on this Quality Engineer role in Cork please contact Cliona O'Malley on 091730022 /
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