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Job Description SummaryJob DescriptionJG1ESSENTIAL FUNCTIONSSupport manufacturing by providing guidance regarding quality documentation/specifications, provide assistance with quality notifications/rejections to ensure product is properly contained, conduct quality audits, partner with quality engineers and manufacturing to investigate root cause of manufacturing and/or customer complaint related issues and prevent reoccurrence, assist quality and process engineers with inspections/testing associated with validations and engineering studies, use SAP to complete material movements. Good working knowledge of product and manufacturing processes. Interpret drawings and specifications. Ability to communicate clearly with all levels of associates. Proficient in all aspects of Quality Control procedures and possess a detailed knowledge of product components. Understand plant quality release requirements on assembled and / or finished use products, where applicable. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.PRIMARY RESPONSIBILITIESResponsibilities include but are not limited to:Give direction concerning product quality using quality documentation. Work with quality engineers, quality inspectors, and to ensure quality notifications are handled properly. Work with quality engineers and manufacturing to improve quality and reduce quality notifications. Conduct quality audits. Work with quality engineers and team leaders to address audit findings. Complete quality notifications completely and accurately. Provide training to associates regarding Quality Notifications and protocols (rework, sort, etc.). Review inspection results and documentation. Perform first piece inspections. Assist with making changes to quality documents as necessary. Utilize SAP for the revision of quality documents. Utilize SAP/FlexNet for product hold and release. Understand, use and enforce ISO standards and FDA regulations. Ensure that policies, procedures and specifications are followed. Read, interpret and explain specifications and prints as required. Understand, use and interpret quality systems policies and specifications. Train and certify co-workers in inspection techniques and using gages. Other duties as required to support the needs of the business.DELIVERABLES
Support project work (testing associated with validations, engineering studies, Vision projects, etc.).
Complete Root Cause investigations.
Complete and/or approve First Piece inspection for process startup.
SUPERVISION: This position will not supervise othersQUALIFICATIONS AND REQUIREMENTSMinimum Education:This position has the following educational requirements:H.S, Diploma/GEDAssociates Degree preferred in a related field: Adult education, Manufacturing, Quality, related disciplineMinimum Experience:
2 years’ experience working in Medical Device manufacturing.
4 years manufacturing experience; experience performing inspections in a manufacturing environment.
Minimum Knowledge, Skills, or Abilities (KSA’s):Basic or Simple KSAProject management skillsData driven skillsProblem solving skillsProficient/ Working KSAISO Standards/FDA RegulationsCommunication skillsQuality InspectionsDetail OrientedSAPQN InvestigationAdvanced or Specialized KSANonePhysical Capacity Profile: 2+Primary Work LocationUSA NE - Columbus (East)Additional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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, military eligibility or veteran status, or any other protected status.
