Sr. Supplier Engineer
1266 Kifer Road Sunnyvale, CA 94086
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems to maximize Patient Value.
Roles and Responsibilities:
• Validate Supplier processes
• Document Supplier Change Requests in SAP.
• Execute Engineering Change Orders using Agile.
• Request supplier data such as Cpk, Correlation, Gage R&R etc.
• Investigate and resolve Supplier related non-conformances; includes the following:
• Incoming quality inspection failures
• Failures during assembly
• Audit findings
In order to adequately perform the responsibilities of this position the individual must possess:
• BS degree in Engineering or equivalent
• 8+ years Supplier Engineering, Process Engineering, Quality Engineering or related field
• Excellent written and verbal communication skills.
• In-depth analytical and trouble-shooting skills, and inspection and test techniques
• Experience in evaluating and supporting Supplier-related issues
• Ability to read and interpret detailed specification drawings and communicate technical information
• Strong knowledge of quality systems and compliance to help suppliers resolve major audit findings.
• Advanced computer experience using Windows, MS Office Suite, SAP (or other ERP system), and Agile (or other document control system)
• Ability to travel to suppliers on an as needed basis - domestic and international (max travel per quarter is 15%)
• Knowledge of root cause analysis, Corrective and Preventative Actions (CAPA) or Supplier Corrective Actions (SCAR).
• Strong Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards and working with suppliers to resolve audit findings.)