Senior Supplier Quality Engineer

at Ultima Genomics

We are looking for a highly motivated Senior Supplier Quality Engineer to join our team!

You are detail-oriented, data-driven, and enthusiastic about helping develop suppliers, with the goal of ensuring they consistently meet company requirements. As a Senior Supplier Quality Engineer, you will be given the opportunity to implement industry best practices as it relates to supplier evaluation/qualification and monitoring as well as work with internal cross-functional teams to ensure we have a robust supplier lifecycle process.

How You’ll Contribute

• Supplier Management
  • Develop, monitor, and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the appropriate stakeholders
  • Compile, analyze, and summarize supplier performance data for periodic management reviews
  • Own, manage, and drive to completion Supplier Change notifications
  • Partner with Procurement, R&D, Operations, and Suppliers in the investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
  • Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
  • Plan, schedule, execute, report, and follow-up on supplier audits
  • Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
  • Participate in component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
• Manufacturing Support
  • Review, investigate, disposition, and drive to completion Nonconforming Material reports (NCMs) and Corrective and Preventive Actions (CAPAs)
  • Support internal and third-party audits
  • Participate in Material Review Board (MRB) meetings
  • Provide technical support and guidance to the Quality Assurance group
• New Product Introduction (NPI) Support
  • Partner with cross-functional teams to define requirements for supplier selection, evaluation and qualification as part of design transfer activities
  • Participating in the supplier selection process and implementing the appropriate supplier quality controls during the development process
  • Partner with R&D Engineering team to develop and qualify tooling/test fixtures to be used by suppliers for component/assembly acceptance
  • Partner with R&D Engineering to review DFM requirements
• Other duties as assigned

 Qualifications, Skills & Abilities

• BS in a related engineering discipline and 5+ years of relevant experience or equivalent experience
• Experience in the biotech industry is strongly preferred
• Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
• Strong technical writing skills
• Effective communication skills across all levels of the organization
• Must be proactive, self-motivated, and able to work independently with minimal supervision
• Ability to work independently in a fast-paced environment while managing multiple priorities
• Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
• Able to lift objects weighing up to 25 lbs
• Ability to travel up to 10% of the time

At Ultima Genomics, your base pay is one part of your total compensation package. This role pays between $110,000 and $125,000, if performed in California, and your actual base pay will depend on your skills, qualifications, experience, and location. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes: medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending & health savings account; paid holidays; paid time off; employee assistance program; and other company benefits.