Senior Software Quality Engineer

Bd Medical

Limerick

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. Role Requirements. 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: Defect Tracking. Agile Scrum. Verification and Validation Planning/Testing. Software Integration Testing. Risk Management. 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. Qualifications: 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! This job originally appeared on RecruitIreland.com.

2012 days ago