Supplier Quality Engineer Job at Stark Pharma Solutions Inc, California

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  • Stark Pharma Solutions Inc
  • California

Job Description

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)

Job Overview

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 Responsibilities
  • Complete 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.

Required Qualifications
  • 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.

Key Attributes
  • 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.

Job Tags

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