BD (Becton, Dickinson and Company) QA Engineer 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 .
Reporting to the Quality Manager responsible for Quality Systems, the Quality Engineer will be dedicated to quality system development, and advancement ensuring greater compliance across the facility. They will play a key role in the development and execution of plans to ensure compliance to the new MDR regulations and also ensure systems developed will allow for continued compliance to standards as they are revised.
The role requires a high level of ownership and enthusiasm.
· Review and assess risk management and validation requirements throughout product realisation;
· Perform risk management and validation activities in support of quality system compliance;
· Implement changes in quality management system policies and procedures in line with best practice and systems excellence;
· Effectively communicate with internal and external customers;
· Participate in and support external audit activities;
· Drive CAPA and continuous improvement activities as required;
· Perform internal audits, identify gaps and recommend improvement measures;
· Development of robust action plans, projects and verification activities for prevention of compliance findings across all aspects of the quality system;
· Developing detailed gap analysis and executing plans to maintain compliance to all internal and external standards and procedures;
· Prioritising improvement areas based on risk assessments;
· Systems focus on all key aspects of product realization including R&D, Manufacturing and Logistics activities.
The successful candidate will have a minimum of 3 years in the medical device or pharmaceutical industry. Knowledge of quality management systems ISO 13485, GMP, etc. The ideal candidate will hold a Third Level Science/Engineering/Technical qualification.
This includes alignment of the quality system with changes in global and corporate quality management standards, policies and regulations. Assess compliance to global and corporate quality management system standards and regulations including MDR, ISO 13485, CFR 11820 and CMDR.
You will have excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines. Problem solving techniques with excellent organisational skills & attention to detail and adaptability.
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
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.