BD (Becton, Dickinson and Company) Quality Engineering in Villamarzana, Italy
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our vision for Quality at BD
In our Quality team, we collaborate on a large scale, focusing on making sure everything is accurate, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.
About the role
At BD, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Quality Engineering is key position to support in different ways the organization, helping to maintain the QMS, Continuous Improvement in Product Quality and Systems, and technical quality support for different projects that encompass new process, different product configuration, equipment, test instruments under ISO13485 requirements.
Main responsibilities will include:
Quality Engineering is responsible for supporting MDR transition project, direct responsibilities are on process FMEA development for Villamarzana site and direct support to Bosnia site, supports also Technical Files updates and associated processes to meet MDR requirements for these manufacturing sites. Works multi-functionally in the development and or maintenance of pFMEAs.
As part of the Quality Engineering activities, he will support Calibration process for Villamarzana. The Engineer is involved in resolving the equipment problems under calibration program. Keeps updated BMRAM software related to the instruments data base.
Duties / Accountabilities:
Demonstrates working knowledge of quality engineering policies, principles and standard methodologies
Demonstrates working knowledge of ISO 13485, ISO14971 and MDR 2017/745 requirements
Applies working understanding of regulatory requirements (cGMP, ISO, etc.) to support work with minimal supervision
Perform Risk Analysis for process Failure Mode and Effect Analysis and participate with different departments and sites for the process evaluation associated with production of Villamarzana and Bosnia
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended to support pFMEA
Works with moderate mentorship in own area of knowledge to make technical decisions about product or processes as part of pFMEA and calibration.
Support internal and external audits related to Risk Management and Calibration
Validation support / MSA
Provide different kind of reporting quality data information
Participate in projects associated with MDR transition and calibration.
Bachelor's degree (Engineering preferable)
First significant experience required
Proficient level of English
Click on apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work Location
ITA Villamarzana - Via G. Matteotti
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.