Regulatory Labeling Validation Engineer - iMPact Business Group
Fremont, CA 94538
About the Job
Our client's Neurovascular division strives to propel the field of stroke care through continuous, purposeful innovation that powers meaningful outcomes. Focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions, discover all the ways we pursue our mission and deliver on our promise.
The R&D Labeling Quality Engineer will be a member of the Sustaining Packaging team with responsibilities for design and development of packaging components and labeling artwork (labeling can include translation management), design verification, and shelf-life testing.
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a EUMDR Regulatory Labeling Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
- Supporting set up of new labeling templates for design changes and new product introductions and new product families using a labeling system.
- Researching and building knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension.
- Driving continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices.
- Preparing for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room.
- Leading recertification and other compliance projects by managing key activities with stakeholders to execute required changes and sometimes determine alternate design directions.
- Leading structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation.
- Providing input to the creation of training and communication materials that can be used by self or other staff to convey new or updated processes.
- Modifying existing and creating new quality system documentation (work instructions, standing operating procedures, forms, checklists, and templates).
- Providing weekly summary of activities, creating project plans, prioritizing, and effectively communicating updates to customers.
Requirements
- Bachelor's Degree
- 4-6 years of relevant experience.
- Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator) experience.
- Computer Aided Drafting (CAD) - Solidworks, AutoCAD experience.
- Database driven labeling system such as Prisym, Label View, Loftware, BarTender, NiceLabel, and Easy Label
- Experience in website design and testing.
- Microsoft applications (Word, Excel, PowerPoint, and Visio) experience.
Requirements
- Bachelor's Degree
- 4-6 years of relevant experience.
- Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator) experience.
- Computer Aided Drafting (CAD) - Solidworks, AutoCAD experience.
- Database driven labeling system such as Prisym, Label View, Loftware, BarTender, NiceLabel, and Easy Label
- Experience in website design and testing.
- Microsoft applications (Word, Excel, PowerPoint, and Visio) experience.