Quality Systems Engineer Specialist

hace 1 día


Alajuela, Alajuela, Costa Rica Johnson And Johnson A tiempo completo
Company Overview
Innovative healthcare solutions at Johnson & Johnson empower us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in medical devices, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.

Job Description
As a Quality Systems Engineer I, you will perform work under supervision in compliance with FDA, European MDD/MDR, and other international regulations. Your general scope is to support the NCR process, data analysis, internal and external audits, and monitoring of key process metrics.

Key Responsibilities:
  • Assist with audit activities.
  • Participate in quality system activities and support internal and external audits.
  • Compile quality metrics for trending purposes.

Required Skills and Qualifications
A Bachelor's degree in related engineering is required. Between 0-1 years' experience in the medical devices industry is preferred. English proficiency (B2 level as a minimum) and basic knowledge of cGMP, FDA 820 QSR, and ISO 13485 or other Quality Systems are essential. Experience in the medical device industry, FDA/ISO audits, NCR, and CAPA experience is a plus.

Benefits
We offer a dynamic work environment, opportunities for professional growth, and a chance to make a meaningful impact in the lives of patients worldwide.

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