BD (Becton, Dickinson and Company) Quality Engineer in Limerick, Ireland

Job Description Summary

The 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 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.

Job Description

Be the Difference in Quality Engineering

The 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 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.

The Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Quality Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.

The position requires a self-motivated, self-directed individual able to handle multiple projects across multiple business units and tasks utilizing a high level of written and oral communication skills. In addition the incumbent will be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of quality engineering and new product development and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities. The Sr. Quality Engineer reports to the Quality Manager, RCI.

Be the Quality Engineer

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/HW Development Guidance

· Help Facilitate Document review and approval with Medication Management System (MMS) BU.

· Assist with Test Case Reviews.

· Review and approval of Verification and Validation plans/protocols/reports.

· Develop Test Method Validation documents.

Risk Management

· Facilitating and coordinating the risk management process.

· Responsible for leading the Risk Management Team in determining if new risk management documents will have to be created or if existing product family risk management documents will be updated.

· Develop the following risk management documents:

o Risk Management Plan

o Risk Analysis

o Risk Management Report

o DFMEA

General Guidance for Project/New Employee Onboarding

· Accessing C2C training/understanding MMS training requirements

· Accessing SAP

· Accessing TFS

· Accessing Sharepoints

Test Instrument

· 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)

· IQ/OQ review/approval

· Liaison with Field Service Engineers to ensure proper documentation of servicing

Technology Development Understanding/Guidance

· Help project teams understand process and requirements

· Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.

· Creates and supports documentation.

Qualifications:

· A minimum of 2 years of experience working within a quality function.

· A minimum of 2 years of experience working in a FDA or ISO regulated environment.

· A minimum of a bachelor’s degree is required.

Assets:

· BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science

Certified Quality Engineering (CQE) preferred.

· Robust understanding of QSR, Design Control, ISO, Product Risk Management (ISO 14971) and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.

· Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.

The BD Difference

BD, founded in 1897, is a global medical technology company with over 40,000 associates in over 100 countries. We create specialized devices, solutions and systems to address many of the world’s most pressing healthcare needs. We operate under a single purpose: “to advance the world of health”.

We have been a strong employer presence in Ireland for over 50 years. Join us and be our newest team member making the difference!

Primary Work Location

IRL Limerick - Castletroy

Additional Locations

Work Shift

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.