Staff Quality Engineer - CAPA

Becton Dickinson Medical Devices • San Diego, CA

13d • Onsite

About The Position

The Staff Quality Engineer will support the implementation of the CAPA system for the Infusion MMS business unit, in accordance with QMS policies and procedures. This role supports the development and maintenance of the CAPA process to ensure corrective actions are timely and effective according to established requirements. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

• Bachelor’s degree in Engineering or Science
• Experience in medical device industry required
• Minimum 8 years experience in technical Quality Engineering space
• Knowledge of FDA regulations and ISO standards
• Excellent communication skills, both written and verbal
• Ability to work independently and collaboratively as part of a team
• Strong analytical and problem-solving abilities
• Proficiency in Microsoft Office Suite

Responsibilities

• Manages the Implementation of CAPAs and the associated action items.
• Works with the CAPA Owner to identify project planning resources for defined action items and develop a Targeted Duration Request, as needed.
• Initiates action items in TrackWise for planned action items approved in the CAPA.
• Supports Action Owners with action item completion and summaries.
• Supports CAPA Owners with the Implementation Summaries and/or Extension Requests.
• Works with the CAPA Owner to develop and finalize the VOE Plan
• Ensures CAPA phases are approved by the defined due date in TrackWise .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees