BD (Becton, Dickinson and Company) Quality Engineer - Product Support in Kornye, Hungary

Job Description Summary

As directed by the Quality Manager, the Quality Engineer – Product Support:

Accountable for supporting product transfer activities through the application of Quality engineering skills for life science research reagents.

Lead/participate in sustaining quality engineering activities/projects.

Provide training and technical assistance to staff and contractors.

Job Description

Product transfer and sustainment:

  • Fully understand all product requirements and technical factors that influence consistent quality outcomes. Develop quality solutions in order to support manufacturing or quality control/assurance activities.

  • Is a team member representing Quality on new product implementation/product transfer and sustaining engineering projects.

  • Reviews and has Quality Engineering approval authority for new and modified process specifications including product performance specifications, test methods, etc.

  • Develop technical documentation to include, but not limited to specification requirements, functional descriptions, and systems specifications.

  • Produce technical reports, studies, briefing materials and other technical documentation as required.

  • Prepare reports and provide support for the Material Review Board meetings.

  • Support the creation of Certificates of Analysis, Origin, and/or Compliance as needed.

  • Consistent application of technical principles, theories, concepts and quality sciences / tools.

  • Ensures that all production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.

Quality System:

  • Provide support for the continued development, implementation and improvement of the Quality System.

  • Ensure quality departmental procedures and SOPs are up-to-date at all times.

  • Ensure compliance to ISO9001 or other appropriate Standards, in addition to company policies or legal requirements.

  • Maintain working knowledge of current industry and international standards. Keeps abreast of the US and non-US regulations affecting own area of supervision/management and complies with those regulations. Initiates changes to BD practices and procedures to support compliance requirements. Communicates the need for compliance to member of own functional area. Brings regulatory compliance questions/issues to the attention of the next level of management.

CAPA:

  • Provide support to ensure every CAPA is appropriately reported and analyzed, effectiveness verification completed.

Audits (internal, external, supplier):

  • Perform / assist supplier and internal/external quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Laboratory Practices.

Validation:

  • Work in a team environment and provide support for qualification/validation activities.

  • Provide analytical and technical support in setting up, collecting, analyzing, documenting, and presenting statistical evidence of the qualification / validation work.

Instrument management:

  • Support the Instrumentation management program, including equipment/instrument approval process, as needed.

Training:

  • Managing/organizing/conducting the training of associates in required techniques, operation of equipment, or other relevant group or department procedures or practices and complete proper documentation.

  • Provide quality trainings, as needed.

  • Participate in assigned cross-training or off-site training as required.

Improvement:

  • Makes measureable improvements to BD Biscience processes and procedures

Reporting:

  • Assures data availability and integrity for all quality related data. Consolidates and reports quality results.

  • Prepares ad hoc or regular reports as needed for quality trend analysis as required by the quality or business leadership team.

May perform other related duties and assignments as required

Primary Work Location

HUN Kornye - Uveggyar

Additional Locations

Work Shift

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.