Senior Supplier Quality Engineer
Katalyst CRO · Sunnyvale, CA · 2 mo ago
On-siteQuality AssuranceContract
Roles And Responsibilities
- Part Qualification Support: Lead Core Product Teams in defining appropriate Part Qualification requirements, including testing and inspection requirements.
- Value Engineering and Quality Improvement: Complete Production Part Qualification Process deliverables such as Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis.
- Risk Analysis and Corrective Actions: Perform product/process risk analysis and ensure mitigations are implemented and effective prior to product introduction.
- Manufacturing Process Selection and Development: Identify the correct process for manufacturing the part, consider process quality, long-term capacity, and total lifecycle cost.
- DFM Education: Educate internal customers and suppliers regarding supplier quality, process, and operational capabilities, best value manufacturing methods, and tooling for key supplier processes.
- Change Management: Drive improvements to ISI requirements by proposing and managing changes to specifications and drawings through the ECO process.
- Supplier Change Management: Manage supplier change management projects using the Supplier Change Request process (SCR).
- Status Reporting: Provide status of the readiness (quality, capacity, delivery) of the supply chain for major production process changes.
- Supplier Selection and Evaluation: Work with Product Design, Commodity Managers, and other stakeholders to identify high-capability suppliers necessary for new products based on business needs and supplier capability.
- Supplier Audits: Evaluate new suppliers through informal assessments and formal audits, supporting lead auditors in QMS evaluations.
- Supplier Relationships: Manage supplier relationships to effectively partner with ISI suppliers and foster a collaborative environment.
Skill/Job Requirements
- Education: BS degree in Engineering field
- Experience: 10 years related experience in Manufacturing, Supplier Process Engineering, Design, or related field
- Communication: Excellent written and verbal communication skills
- DFM Experience: Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
- Process Knowledge: Experience with a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity
- Product Experience: Proven ability to motivate suppliers and lead teams to solve difficult technical and process problems in categories such as Machining, Metal Fabrication, Welding, Plastic Injection Molding, Die Casting, Thixomolding, Mechanical Motion Products, Mechanical Motion Control Products, Motion Control Sensors, Medical Gas Line Processing, and Low-Volume High-Mix Production Environments
- Technical Skills: Familiarity with pFMEA, process validation, inspection and test techniques, 21 CFR part 820, ISO 13485, and GDP/QMS methods
- Software: Significant computer experience using Windows, Word, Excel, Access, and ERP Information Systems, preferably SAP
- Travel: Ability to read and interpret detailed specifications and schematics, communicate technical information, and travel to suppliers on an as needed basis (domestic and international)