Overview
Currently seeking a Sr. Manufacturing Engineer to join a Medical Device client to support the Qualification of a Cleaning & Sterilisation Process onto their site. This is an ASAP start, full time and long-term hourly rate contract, primarily on site in East Cork. Ideal candidates possess a strong experience in Medical Device Engineering roles. Validation expertise is essential (IQ/OQ, EQ, PQ, MSA), with a preference for candidates with experience with Cleaning & Sterilisation.
Responsibilities
* Responsible for assisting process improvement and problem-solving manufacturing issues using Six-Sigma tools.
* Providing technical leadership on all product and process issues.
* Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
* Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP).
* Leading technical improvements under the business\' Continuous Improvement Program (CIP).
* Transferring and implementing processes, either from development, or from another manufacturing facility.
* Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented according to New product Development Process.
* Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
* Conduct Gauge R&R studies for products and new processes.
* Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate.
* Observing the Quality Management Systems requirements on site at all times.
* Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
* Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site.
* Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers.
Qualifications
Validation experience is essential (IQ/OQ, EQ, PQ, MSA), with a preference for candidates with experience in Cleaning & Sterilisation. Desired skills include IQ, OQ, PQ, Sterilisation, Cleaning, MSA, and Equipment Qualification.
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