Job Details

Overview

Staff Quality Engineer - CAPA at BD (Tissuemed Ltd). The role supports 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.

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.

Qualifications

• 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

Why Join Us

BD is a leading global medical technology company. We foster an environment where you'll be supported to learn, grow and become your best self.

Salary Range

$124,700.00 - $205,800.00 USD Annual

Location

USA CA - San Diego TC Bldg C&D