Position : Supplier Quality Engineer
Location : Santa Clara, CA (100% On-site)
Experience: 3 - 5 Years
Duration : 12+ months
Citizenship Requirement : US Citizen or Green Card holders only (No visas, OPT, or other sponsorship allowed)
We're looking for a Supplier Quality Engineer to work closely with suppliers and internal teams, driving supplier excellence, cost efficiency, and risk reduction. You'll play a key role in supplier qualification, change management, and continuous improvement to ensure components meet quality, cost, and compliance standards.
Key ResponsibilitiesComplete project and part qualification deliverables: Supplier pFMEA, IQ/OQ/PQ, inspection reports, Gage R&R, and process capability analysis.
Partner with suppliers on cost reduction, capacity expansion, and risk mitigation initiatives.
Select appropriate suppliers and processes considering long-term fit and total cost of ownership.
Manage supplier changes: process optimization, facility moves, new equipment qualification, and line validations.
Initiate and manage engineering change orders to update specifications and drawings.
Drive supplier variance resolution through root cause analysis, CAPA documentation, and corrective actions.
Lead supplier development initiatives, implement best practices (Lean, Six Sigma, SPC, project management), and monitor key metrics.
Provide timely, data-driven supply base health updates and recommendations to management.
Collaborate with suppliers and design engineering on new product introductions, including DFM, ramp readiness, and supplier selection.
Review and resolve customer complaints, manufacturing variance requests, and first article inspections.
Continuously improve supplier performance and prevent recurrence of issues.
BS degree in Engineering or equivalent (Advanced degree preferred).
3+ years of experience in engineering/manufacturing of precision sheet metal, CNC machining, or plastic injection molding parts.
Strong knowledge of manufacturing processes and key quality/capacity input variables.
Proven background implementing Lean, Six Sigma, and SPC programs with suppliers.
Excellent project management, analytical, and problem-solving skills.
Knowledge of 21 CFR Part 820 and ISO 13485 standards.
Ability to interpret detailed mechanical drawings (GD&T) and communicate technical details.
Strong written, verbal, and presentation skills (executive-level communication).
Proficiency in MS Office Suite and ERP systems (SAP or Agile preferred).
CAD (3D modeling) and statistical analysis software (Minitab) experience is a plus.
Experience in medical device or high-volume manufacturing environments is highly desirable.
Supplier management experience is a strong plus.
Self-driven with strong ownership of tasks and deliverables.
Able to influence and motivate suppliers without direct authority.
Comfortable managing multiple priorities simultaneously.
Skilled at building supplier relationships and driving accountability.
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