Quality Systems, Sr Manager

hace 2 semanas


Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo
About the Role

At Boston Scientific, we are committed to advancing science for life. As a Quality Systems, Sr Manager, you will have the opportunity to lead a cross-functional team in developing procedures that will lead to a successful launch of a PMA product containing MOAO and prepare the manufacturing site to host successful inspections by FDA and external audits.

Key Responsibilities
  • Supervise and assure a flawless execution of the corrective and preventive action system (CAPA).
  • Supervise the correct usage of investigation tools and techniques in order to obtain effective corrective and preventive actions over issues managed in different quality systems including eCAPA.
  • Ensure follow-up of action items related to the quality system to facilitate closure of CAPAs and NCEPs as required.
  • Drive a proactive quality culture based on substantial compliance by providing relevant training, coaching, driving actions, and disseminating critical information.
  • Support QA Director during preparation, management, and hosting of external audits.
Requirements

To be successful in this role, you will need:

  • Strong project management skills.
  • A bachelor's degree or above in a technical/science career (Industrial, Electronic, Biotechnology, Electromechanical Engineering, etc.).
  • 10 years of medical experience.
  • Experience hosting quality audits/FDA inspections.
  • 90% English proficiency.
  • Master's degree desirable.
  • ASQ Certification.
  • Knowledge of Six Sigma, Lean, APQP, or similar tools.


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