BD (Becton, Dickinson and Company) Quality engineer II operations in Wexford, Ireland
Job Description Summary
Quality Engineer II to back fill operations role on Project Polaris.
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best in their professions. We are always seeking people who have a passion and commitment to join our Company on its journey in ‘advancing the world of health’.
At the Enniscorthy facility, ClearStream manufactures mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are now recruiting a Quality Engineer II (Operations).
As a Quality Engineer II (Operations), you will participate in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences.
Ensures compliance to quality system requirements as defined by ClearStream Technologies’ procedures, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system.
Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance;
Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods;
Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups;
Applies risk management, change control, and validation principles throughout the product lifecycle;
Supports the divisional corrective / preventive action program by applying root cause analysis and problem-solving techniques and by implementing corrective/preventive actions.
The successful candidate will have a Third Level Qualification and good knowledge of design validation, design transfer and change control principles and techniques and knowledge of pre-production QA principles and techniques (e.g. APQP, PPAP, MSA). Statistical methods and Six Sigma process excellence tools is a plus.
The ideal candidate will have experience in medical device industry or similar industrial environment with good working knowledge of regulatory requirements and Quality Systems techniques. Shown to be a good team member and has experience of participating in team environment. You will lead cross-functional teams to develop risk assessments and risk controls.
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.
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.