BD (Becton, Dickinson and Company) QA Engineer II in Wexford, Ireland
Job Description Summary
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and healthcare worker safety and the technologies that enable medical research and clinical laboratories. Does it sound exciting? Good news, we are hiring!
At the Enniscorthy facility, BD manufactures mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are now recruiting a QA Engineer II (1-year Contract with the possibility of extension).
Reporting to the QA Manager, you will be responsible to assure that all Suppliers, Components and associated activities are appropriately qualified in accordance with local, Corporate and Divisional requirements. Performs supplier audits and on-going supplier surveillance as required; Incorporates risk management, performance and validation inputs as well as applicable Standards and Procedures in planning and implementation of supplier activities. Represents quality interests and concerns on project teams.
The successful person will need to be available for regular travel to the USA to visit our suppliers.
As QA Engineer II you will:
· Performs Quality engineering activities for Supplier and Component Qualification and related activities;
· Develops and maintains supplier quality files;
· Performs supplier audits in accordance with the Audit Schedule;
· Develops supplier qualification plans, protocols and reports as required;
· Establishes alignment with risk management documentation;
· Maintains Approved Supplier List;
· Performs TMV as applicable;
· Develop or assist in development of inspection and test methods per product specifications;
· Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required;
· Development of robust action plans, projects and verification activities for elimination of potential at compliance and CAPA related risks, as required;
· Alignment of the quality system with changes in global and corporate quality management standards, policies and regulations.
The successful candidate will have a minimum of 5 years Supplier Quality experience, coupled with a background in Medical Devices/Pharmaceutical Industry. Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. The ideal candidate will hold a degree in a Science/Engineering/Technical discipline.
You will have experience of preparing technical documentation and a good knowledge of Knowledge of risk management – d/PFMEA; Risk Analysis, Risk Management File, Gauge R&R and Test Method Validation would be advantageous. You will have Lead Auditor qualification and experience. Risk-based and performance approach to drive and prioritise the internal audit schedule across the facility.
This role requires the person to have previous experience of working in process validation planning and execution. You will have proven ability of working within a cross functional team to effectively implement NPD projects, corrective actions etc.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Primary Work Location
IRL Wexford - Enniscorthy
USA - Pre-Acquisition-Location (inactive)
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.