- 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
- 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