Our client, a medical device company in Cork are currently looking to recruit a Labelling Quality Engineer for their site on a 12 month contract.
Job Description / Information
Provide quality engineering support and direction in labelling with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
- Will work within the quality operations labelling team, under minimal supervision, with responsibility for all labelling related activities, including, but not limited to the following:
- Participate in execution and project management responsibility for labelling/packaging for New Product Introduction and existing product updates
- Ownership of packaging related NCR/CAPAs for labelling group and ensures timely closure of all issues in line with corporate guidelines.
- Ensure regulatory compliance in area of responsibility to cGMP?s of all medical device regulatory agencies (e.g. FDA and TUV).
- Review any Change Request activities for the approval and release of drawings, labelling, Directions for Use (DFU) and other labelling components.
- Provide technical support to both the Quality Assurance and Regulatory teams to help investigate and recommend solutions to any package / labelling design related issues.
- Support labelling systems on the manufacturing floor.
- Provide support of new packaging validation ? systems, equipment, process and materials and support of packaging suppliers for new products.
- Act as a resource for product development teams with creating content for Labels and Directions for Use (DFU) manuals.
- Provides guidance to labelling and cross functional teams in problem solving and task execution.
- Build quality into all aspects of work by maintaining compliance to all quality requirements.
- Masters or Bachelor of Science, Engineering or related subject
- Previous experience in industry desirable
- Understanding of Med Device concepts desirable.
- Familiarity with ISO 13485, GDP, GMP concept desirable.
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and quality concepts / theories.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
- Must be willing to work as part of a multi-site team, with some travel required.
- Knowledge of Risk Based and statistical concepts desirable.
- Problem solving and analytical skills.
- Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
- Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
- Accepts change openly and adopts a continuous improvement orientation to the role
- Excellent English (both oral and written)
- Ability to be the voice of Quality when dealing cross functionally
For further information on this Labelling Quality Engineer role in Cork please contact Jenny Dore on 0212066287 / firstname.lastname@example.org
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