BD (Becton, Dickinson and Company) Quality Engineer in Wexford, Ireland
Job Description Summary
We are now recruiting a Quality Engineer for our state of the art facility in Enniscorthy. The successful candidate must be able to apply quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet or exceed performance specifications and regulatory standards.
Participates 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
Provides Quality Engineering representation on cross-functional product development teams
Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance
Leads cross-functional teams to develop risk assessments and risk controls
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
The successful candidate must have a minimum of a engineering or science degree required E xperience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and Quality Systems techniques and e xperience in risk-based decision making and problem-solving.
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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.