Quality Assurance and Compliance Director

hace 7 días


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**Job Summary**

This position provides leadership and guidance for the Quality Assurance and Compliance supporting function at Abbott Vascular Costa Rica. The successful candidate will be responsible for developing functional goals, objectives, procedures, policies, and systems that align with the company's objectives, quality policy, regulatory standards, and applicable regulations.

**Key Responsibilities**

  • Develop and execute organizational and operational procedures and policies that affect one or more groups by utilizing technical/professional knowledge and skills.
  • Monitor compliance with company policies and procedures, including FDA, EUMOR, and ISO regulations.
  • Coordinate, facilitate, and track site management review meetings, quality data reviews, and other operational quality reviews, preventive actions, and provide inputs on the Quality Management System effectiveness.
  • Maintain and implement necessary improvements to ensure site audit readiness for audits.
  • Periodically evaluate and escalate compliance risks and coordinate remediation activities to ensure compliance with applicable requirements.

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

**What You'll Work On**

This position works out of our Costa Rica location in our Vascular division. Our business purpose is to manufacture devices designed to optimize angioplasty procedures, including stents, diagnostic and imaging devices, catheters, guidewires, and vessel-closure devices.

As the Quality and Compliance Manager position, you will be responsible for managing activities and areas that support the shared Quality Services within Abbott Vascular Costa Rica to ensure quality compliance, external audit readiness, risk management, batch release, and receiving inspection and CAPA program activities are executed and tracked by Abbott Quality System requirements and applicable regulations.



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