Lcm Specialist
hace 1 semana
San José, San José, Costa Rica
Global Services Business
A tiempo completo
**Job Overview**
In the Global Services Business, we are seeking a skilled Lcm Specialist to join our team. As a key member of our operations, you will play a crucial role in ensuring the smooth execution of validations and technical documentation for medical devices.
Responsibilities:
- Guide the EM on the validation process and lead the draft and review of protocols and test reports
- Offer onsite support at the EM during the execution phase of validations (IQ, OQ, PQ)
- Draft Validation Strategy, including TMVs
- Review current DHF status for products in scope
- Identify needed strategies and inputs from R&D & other functions
- Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria while devising new approaches to problems encountered
- Update work instructions, part specifications, validation protocols, technical documents, and various forms of reports and correspondence
- Supervise, coordinate and technically revise the work of a limited group of technicians
- Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Communicate business related issues or opportunities to next management level
- Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures