Manage the overall process for writing, approving, implementing and archiving of Work Instruction Change Orders In accordance with Divisional and site procedures.
Ensure compliance with documentation requirements of ISO 13485, ISO 14001, EU Medical Devices Directive, FDA Quality Systems Regulation (QSR), and relevant company policies and procedures.
Overall responsibility for storage, retention and off-site archiving of site-specific documentation and records
Work with engineering staff to assemble and mark-up relevant documents for the Change Order package
Manage and track Change Orders through final approval, liaisons with approvers when multi-site approval is required
Coordinate item master data input / changes with several functions using the appropriate data entry forms
Manage Bill of Material and Routing changes for the site as outline in Change Orders
Make or coordinate changes to drawings and other documentation as outlined in the CO, liaisons with R&D, labeling or Product Support group when design changes are needed
Diversity & Inclusion
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics.
We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.
Must be fluent in English : reading and writing
Experience in quality, engineering or associated fields
Experience in a multi-site global Medical Device organisation would be beneficial
Experience to be applicable to Document and Data control within a certified Quality Management System.
Knowledge of FDA Quality System Regulation and ISO 13485, ISO 14001, Medical Device Directive requirements.
Knowledge of and ability to use personal computers to operate company systems e.g. Oracle, SharePoint, Document Management System, MS Word, Excel, etc