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