Evaluate and take appropriate actions based on internal and external standards for all AMO product and procedure releases and modifications. Analyze and interpret data, using independent judgment to approve, reject, release or rework change documentation submissions on a case by case basis. Analyze and review submissions based on product type, development lifecycle stage and the interpretation of the significance of the proposed change.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Independently assess and judge proposed product and procedure changes for compliance to regulatory and business standards.
2. Conduct final configuration verification prior to product release or change implementation in Document Management System and ERP system.
3. Monitor, direct actions and/or escalate issues regarding the change processing status to meet project plan release deadlines.
4. Guide change initiators in the development of accurate changes.
5. Create and implement system processing improvements.
Minimum 3 years experience in regulated industry, preferably in medical devices. Minimum 3 years experience with MS Office Suite, with Enterprise Requirements Planning (ERP) system, preferably SAP and Product Lifecycle Management system, preferably Agile. Demonstrated ability to communicate effectively, with clear and concise oral and written communication. Spanish or Chinese language proficiency a plus. Ability to interpret and analyze diverse submissions and assess compliance to standards utilizing independent judgment consistently and appropriately. Customer driven with sense of urgency/priority in responding to customers' needs.
AA Degree or equivalent
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