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

Job Description Summary

Job Description

  • This Position will be the Quality Lead

  • Will lead the SQE effort in the next generation of Infusion pump

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

  • 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 supportingDevelopment/OperationsEngineering 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.

  • Participate in Quality Audits as a process subject matter expert.

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

Qualifications

  • Bachelor's degree and 10+ years experience is required; or equivalent combination of education and experience. Preferably in Mechanical Engineering.

  • Experience with managing supplier quality in the production of plastic molding and metal forming processes. Having a familiarity with PCB, PCBA, and electro-mechanical assemblies a plus.

  • 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 have high energy and lots of stamina. 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

#LI-OPS

Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.

Primary Work LocationUSA 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