·Taking direction from Quality Engineer’s/Quality Team Leader as to how best to deploy resources and effort on the operations floor.
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·Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
·Daily production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls
·Regular communication with the Manufacturing Team Members regarding issues, concerns and watch-outs on the lines.
* Actively interfacing with cross-functional team members and suppliers, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets
Inspection
* Assist in the develop and maintenance of sampling and inspection procedures
* Sample, inspect and record inspection results when required
* Control movement of components / products following inspection
* Conduct MRB forums
Quality Improvements
* Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
* Support implementation of 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.
Manufacturing Support
* Support Manufacturing Cell in addressing Quality Metrics, e.g. e.g. CAPA, Validations, NCR, Quality Awareness Tests, Training, ECR’s and Internal Audit Findings.
* Responsible for input to Quality Metrics
* Participate in the development and Continuous Improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
* 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.
* Coordination of MRB activities to the business unit to ensure the timely assessment of potential non-conforming products.
* In conjunction with Team Lead approval, has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. In conjunction with Team Lead approval, also has the authority to order the recommencement of production provided he/she is satisfied that all issues pertaining to the non-conformance have been addressed.
* Support the creation & presentation 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
Customer Complaints
* Give input into the evaluation of Customer Complaints (PER Investigation) as required.
* Problem solving / Trouble shooting of customer complaint investigations, coordination of root cause and risk assessments associated NC’s and Risk Assessments where required.
NCR/CAPA
* Support the NCR/CAPA Process.
* Participate in risk assessment activities and ensure that all failure modes in process have been identified and addressed.
* Participate in 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.
Validation
* Assist in completion of equipment validation ((VP, IQ, OQ, PQ, MSA, IPF’s, PSP’s, FR’s etc.).
* QA review and approval of unplanned Pemac routines.
Auditing
* Participate in Internal Audits as required and Supplier Audits. if required.
* Support site during External Audits. (i.e. FDA, IMB and BSI).
Risk:
* Understand and ensure compliance to ISO 14971 ‘Risk management’.
* Ensure that the Top Down Risk Documents, Bottom Up Risk Documents and Attribute Charts are current and live.
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