BD (Becton, Dickinson and Company) Senior Software 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.
Be the Senior Software Quality Engineer
The Senior 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 Sr. 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.
Your Main duties will include:
Quality Systems Development- Develop a Quality system to support design activities, provide guidance and quality oversight to ensure projects are aligned with regulatory and industry requirements. i.e. IEC 62304.
Help facilitate document reviews and assist with test case reviews.
Create receiving and material handling SOP’s and OOS SOP/Investigation Management.
Help project teams understand process and requirements, help facilitate technology integration, provide guidance to team and application of design controls 21CFR 820.30 for new product development.
Create and support documentation
The successful candidate must have 5+ years’ experience working in a Software Quality Design or Software Testing role in a Medical Device Environment.
You must have knowledge/experience in the following:
Verification and Validation Planning/Testing
Software Integration Testing
Experience in Manual/Automation Testing
Working with standards
Good attention to detail in reviewing plans/protocols/reports
Working in Medical Device environment (FDA regulated, ISO13486)
Experience or strong understanding in IEC62304 – Medical Device Software
Design Control experience for 21CFR Part 820 or ISO 13485
Good Documentation Practice
A minimum of 5 years of experience working within a quality function.
A minimum of 5 years of experience working in a FDA or ISO regulated environment.
A minimum of a bachelor’s degree is required.
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
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.