Sr. Supplier Quality Engineer ( Electro Mechanical )

Becton Dickinson and   •  

San Diego, CA

Industry: Medical Equipment

  •  

8 - 10 years

Posted 386 days ago

This job is no longer available.

Job Description

  • 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 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.
  • 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 8 to 10 years experience is required; or equivalent combination of education and experience. Preferably in ElectricalEngineering.
  • Experience with managing supplier quality in the production of PCB, PCBA, and electro-mechanical assemblies.  Having a familiarity with plastic molding and metal forming processes 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.

Job ID R-24786