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.
- 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 / email@example.com
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