Description
I have an immediate opening for a Quality Engineering with one of the most innovative and highly respected medical device companies in Cork. This is an excellent opportunity to work in a company that really values and looks after their employees. This is a permanent position with a very attractive salary plus benefits.Description
- Provide effective and responsive QA support to Operations to resolve in-house & customer issues.
- Drive and implement plant wide quality system improvements.
- Support/ act as local subject expert for review, creation and training of Local, Divisional & Corporate procedures.
- Daily production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls
- Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, Validations, NCR, Quality Awareness Tests, Training, ECR's and Internal Audit Findings.
- Responsible for input to the Monthly Quality Metrics
- Participate in the development and Continuous Improvement of the manufacturing processes for existing and new products.
- Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
- Coordination of MRB activities to the business unit to ensure the timely assessment of potential non conforming products.
- Create & present the Monthly Business Unit review Slides and Represent Quality at this forum.
- Represent Quality at the Weekly FPY (First Pass Yield) forum; Review the FPY Slides for trends and update as required from a Quality perspective
- Develop and maintain sampling and inspection procedures
- Ensure control movement of components / products following inspection
- Ensure that during manufacturing product is sampled, inspected and recorded inspection results when required
- Evaluation of Customer Complaints (PER Investigation) as required.
- Determine whether a Product Hold is required and document accordingly through the Risk and Product Field Action (PFA) Process.
- Manage NCR/CAPA Process.
- 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, Six Sigma, etc.
- Ensure that Containment of product is properly addressed and Documented
- Ensure that Corrective Actions clearly actioned and documented.
- Assist in the development, review and approval of process and equipment validation (VP, IQ, OQ, PQ, MSA, IPF's, PSP's, FR's etc.).
- Participate in Internal Audits as required and Supplier Audits if required.
- Understand and ensure compliance to ISO 14971 'Risk management'.
Minimum Requirements
- Degree in Engineering, Science or equivalent is required (NFQ level 7)
- Minimum of 2 years experience in a QA role.
If you feel you are a good fit for this role please apply directly to this advert or call me, Derek Sheridan, on for immediate consideration.