BD (Becton, Dickinson and Company) Supplier Quality Engineer II in Holdrege, Nebraska
Job Description SummaryThe Supplier Quality Engineer manages the supplier quality program covering raw materials that are produced to detailed specifications. Implements and maintains a comprehensive vendor qualification and certification program to ensure that incoming components/materials comply with the product specifications and comply with the BD quality policies, regulatory requirements and safety regulations.
Manage the selection, qualification, and certification of responsible suppliers to provide materials that meet specifications for production requirements.
Applies suppliers when nonconformaces occur, as neede with accepted quality enginner tools; such as root cause analysis, PFMEAs, Risk mitigation, Validation and DOE, sampling plans.
Institute and maintain a dock to stock program through aggressive vendor interaction.
Analyze, summarize, and report incoming inspection data to advise management of vendor performance.
Maintain supplier relationships that encourage technical input and contributions, as requested, concerning new products, processes, ideas, and improvements. Initiate actions required to maintain the supplier performance at high level.
Interface with the buyers, quality engineers and manufacturing personnel to review customer complaints and identify improvements required for raw materials and components.
Identify, develop and qualify alternate suppliers of raw materials. Coordinate testing and document test results for each raw material/vendor.
Perform plant GMP audits and participate in corrective action.
Accumulate and prepare quality information reports on a timely basis.
Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Other duties as assigned.
BS degree in engineering or scientific discipline with minimum 3 years of experience in quality or manufacturing -OR- AS degree in engineering or related field with a minimum 8 years of sufficient experience.
Project management tools and advanced communication skills required.
Additional and Preferred Skills and Qualifications
Medical device or pharmaceutical experience preferred.
ASQ certified Quality Technician (CTQ), ASQ QE certification, and certified Quality Auditor (CQA) or auditing experience preferred.
Experience with analytical problem solving skills, technical writing skills, and Root cause analysis preferred.
Process validation, Design of Experiment (DOE), 21 CFR 820-21/211 cGMP, ISO 13485-9001 experience preferred.
Experience with Minitab, SAP, and Trackwise preferred.
Continuous Improvement experience and Six Sigma Green Belt certification/training is a plus.
Primary Work LocationUSA NE - Holdrege
Becton, 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