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BD (Becton, Dickinson and Company) Staff Quality Engineer (Supplier) Molding in San Diego, California

Job Description Summary

Support all aspects of the Supplier Quality Assurance function for new product introduction. Work in a team environment with suppliers to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all requirements. Leads root cause analysis and provides corrective action feedback to prevent line stops due to supply issues. Ensures the robustness of product builds following new product introductions to ensure continuity and improvement in supplier capability.

Works on multiple phases or sub-tasks of projects or entire projects of high complexity, reviews project milestones and/or on completion with Senior Management.

Job Description

  • Work with suppliers to establish and maintain controlled manufacturing processes utilizing PFMEA.

  • Responsible for molding process qualifications using scientific molding approach

  • Work with suppliers to establish control methods suitable to the nature of the parts they supply.

  • Leads teams and manage product focus groups working with suppliers.

  • Work with suppliers on measurement methodologies.

  • Build relationships with suppliers to ensure all levels of manufacturing understand BD requirements.

  • Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive action.

  • Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including BD and Suppliers.

  • Responsible for reporting of quality trends and information to management on the performance of suppliers.

  • Traveling is approximately 25%-40%.

  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategies for developing new suppliers.

  • Work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements.

  • Follow up non-conformances during-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation.

  • Work Closely with QA team to manage suppliers to ensure the product quality

  • Supports new product/design change launches to ensure that supplier quality meets the required standards

  • Facilitates root cause analysis and corrective actions of supplier quality issues

  • Performs on-site supplier visits for root cause analysis and verification of correction actions of supplier quality issues

  • Reviews supplier manufacturing processes, collaborates with suppliers on process improvement and value enhancement opportunities

  • Promotes the use of techniques for continuous improvement such as Lean, Six-Sigma, Poke-Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)

  • Leads supplier validation audits using advanced product quality planning (APQP).

  • Provides concise, complete and accurate documentation of inspection results relative to area of responsibility. In appropriate functional areas, this refers to supporting inspection and test status requirements defined by regulations, engineering product specifications or Control Plans, Production Part Approval Process (PPAP) approval or product warrant submission

  • Facilitates the escalation of unresolved supplier quality issues within assigned projects and suppliers

  • Monitors and reports on supplier product quality and performance

  • Reports on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system

  • Leads quality audits

  • Undertakes special projects as required

  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategies for developing new suppliers.

Qualification:

  • Bachelor's degree in engineering and 13+ years’ experience is required; or equivalent combination of education and experience.

  • Must have experience with managing supplier quality in the production of plastic Injection Molding parts.

  • Proven experience with scientific molding

  • Experience setup or maintenance of 3rd party contract manufacturers

  • Direct experience with supplier producing parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 20, EN46001, etc.) preferred.

  • Must have knowledge of Quality Engineering discipline, including statistics.

  • Strong working knowledge of DMAIC \Six Sigma problem solving process. Belt certified a big plus.

  • Competent in Process Audit, CAPA, PPAP, Equipment Validation.

  • Candidate must be self-driven. Must be a team player, and have a strong work ethic.

  • Must have good communication skills.

  • Candidate must be able to work autonomously and independently.

  • Automotive / Aerospace experience acceptable

  • TS16494 / ISO9001 or ISO 13485

  • Certified Lead Auditor

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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, or any other protected status.

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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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