BD (Becton, Dickinson and Company) Senior Quality Engineer in Limerick, Ireland
Job Description Summary
The Sr. Quality Engineer is accountable for supporting the Research Center Ireland (RCI) site, RCI Project teams and/or other projects intended to enhance RCI’s operational effectiveness including the initial creation of a Quality Management System for the RCI site. The Sr. Quality Engineer focuses on the creation of quality processes and procedures at the RCI site which support design control, process control & validation, supplier management and technology transfer based on industry and BD best practices.
Quality Systems development
Begin to develop Quality system to support design activities
Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Support new product development activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development.
Guides the successful completion of major programs and may function in a project leadership role.
SW Development Guidance – support lab automation activities
Help Facilitate Document review and approval with Diagnostic Systems BU.
Assist with Test Case Reviews
General Guidance for Project/New Employee Onboarding
Accessing C2C training/understanding DS training requirements
Test Instrument Consumables/Reagent Control
Create Receiving and material handling SOPs
Temperature Records Management (e.g. temp charts, OOS, etc.)
OOS SOP/Investigation management
Lab Equipment Controls
Calibration/PM – Managing, reviewing/approving/OOS investigations
Blue Mountain RAM Access/Management (Data entry)
Liaison with Field Service Engineers to ensure proper documentation of servicing
Technology Development Understanding/Guidance
Help project teams understand process and requirements
Help facilitate technology integration (i.e. transfer to GPDS)
Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.
Creates and supports documentation.
Primary Work Location
IRL Limerick - Castletroy
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.