Our client, a medical device company in Cork is currently looking to recruit a Labelling Engineer for their site.
Why this role
- Top employer in Cork
- Join a global medical device company
- Excellent location
- Subsidised canteen, excellent social club and big company events
- Early Friday finish
Why will I be doing
- Responsible for the final review and co-ordination of labelling activities for all product labelling into the production environment.
- Ensures effective planning and management of timelines for all aspects labelling and control of release into the production environment.
- Decisive, self-motivated/capable of working on own initiative, and able to prioritize and a proactive approach.
- Assist in review and Windchill change notice activities for the approval and release of other packaging components i.e. DFUs, Cartons, Pouches.
- Monitor and ensure compliance with local and Corp policies and procedures.
- Create, review and maintain curriculums associated with GLS (Global Labelling System) and associated processes.
- Work independently to schedule and complete activities necessary to meet projects & production timelines.
- Provide day to day GLS system support to all established Production lines and NPI (New Product Introduction) Projects.
- Develop, maintain and enhance relationships with global counterparts in Packaging/Labelling, Marketing, Regulatory and Quality functions.
- Demonstrated ability to identify and work with cross functional organizations to implement label designs, packaging components and in the problem solving of labelling & packaging related issues as required.
- Participate in global packaging and labelling projects, to ensure Cork is at the fore front and is involved in any testing/proposed changes on both existing and new products.
- Familiarization with Medical Device labelling to 21 CFR 801 an advantage.
- Establishes and supports a work environment of continuous improvement that supports Quality policy, Quality System & the appropriate regulations for the area.
- Support relevant non-conforming event and corrective and preventive action (CAPA) monitoring progress where applicable and drive through to completion for all action items pertaining to label issues, including problem solving to resolution, root cause analysis and implementation of corrective item.
- Communicate to teams and management on the progress of labelling related projects.
- Represent the site as audit facing SME for Product Labelling and the associated Global & local processes & procedures.
- Ensure audit readiness at all times and participate in Incident Review Board meetings on a quarterly basis.
What Do I Need
- Understanding of packaging and labelling processes and how they fit into the overall product deliverables in line with the NPI process.
- Knowledge of Change Control Systems, Bill of Materials, Preventive & Corrective Action systems, Labelling Management systems etc. Knowledge of Windchill, MES, SAP, eCapa, Prisym applications an advantage.
- Excellent written and verbal communication skills, with a high level of attention to detail.
- Strong command of MS Office – Word, Excel, Visio, PowerPoint.
- Knowledge of EU MDR requirements is an advantage.
- Experience in the medical device industry is an advantage.
For further information on this role please contact Jenny Dore on 0860449371 / email@example.com
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