BD (Becton, Dickinson and Company) Quality Engineer- Validation & Inspection in Kornye, Hungary
Job Description Summary
Main Purpose of the Position
As directed by the Quality Manager, the Quality Engineer-
Validation & Inspection:
•Responsible for Facility Qualification, Process and Software Validation and also provide support for Equipment & Instrument Qualification activities.•Responsible for incoming and final inspection•Responsible for the quality processes of supplier selection, approval and assessment
Primary Responsibilities and Duties
•Work in a team environment to identify resources (internal, external) and develops qualification plans & schedules •Manage the qualification schedule for the project and ensure deliverables are met and documented per the project plan and Validation master schedule•Ensure all related qualification documentation is fulfill business & technical requirements; all strategies, plans, protocols, completion reports or any type are complete, comprehensive, technically sound and accurate•Oversee authoring of qualification protocols, plans and reports as needed and review work of others.•Provide analytical and strong statistical support in setting up, collecting, analyzing, documenting, and presenting evidence of the qualification work.
Incoming and final inspection:
•Leading the incoming and final inspection team•Ensure inspections are done according to the procedures•Ensure fulfill inspection KPIs •Manage inspection related issues, non-conformances and investigations
•Lead supplier and some internal quality system audits as a means of evaluating the effectiveness of the established Quality System•Participate in supplier selection, approval and assessment process
Requires a minimum of a Bachelor’s Degree in engineering
A minimum of 3 years relevant experience with quality assurance and validation
Experience with biotechnology/laboratory/medical devices/pharmaceuticals, manufacturing processes and products.
Experience with hands-on validation planning & execution activities
Demonstrated experience in training on validation practices.
Applied knowledge of ISO9001 with ability to design, document and implement clear and straightforward processes and procedures
Effective Analytical & Statistical Skills (Minitab)
Experience with people management
SAP QM knowledge highly preferred
Experience with Supplier Quality Assurance process preferred
Strong communication, organizational and project management skills.
Fully bilingual – English – Hungarian (written and spoken)
Primary Work Location
HUN Kornye - Uveggyar
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.