Medical Device Quality Assurance Professional
hace 4 días
At Johnson & Johnson, health is everything. We believe that our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Our expertise in medical devices enables us to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.
Job Summary
The Quality Systems Engineer I will perform work under supervision in compliance with FDA, European MDD/MDR, and other international regulations. This role requires frequent use and general knowledge of industry practices, techniques, and standards. You will assist with audit activities, participate in quality system activities, and compile quality metrics for trending purposes.
Main Responsibilities:
- Support the NCR process and data analysis.
- Monitor key process metrics.
- Interface with Subject Matter Experts regarding audit requests.
Requirements
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.
Career Development Opportunities
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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