Senior Supplier Quality Assurance Specialist

4 days ago

Fremont, California, United States Ultima Genomics Full time
Job Title: Senior Supplier Quality Engineer

Ultima Genomics is a rapidly growing life sciences technology company that is revolutionizing the field of genomics. We are seeking a highly motivated and detail-oriented Senior Supplier Quality Engineer to join our team.

About the Role

The Senior Supplier Quality Engineer will be responsible for ensuring that our suppliers consistently meet our quality requirements. This will involve developing and implementing supplier evaluation and qualification processes, as well as working with internal cross-functional teams to ensure a robust supplier lifecycle process.

Key Responsibilities
  • Develop, monitor, and analyze supplier performance metrics to identify improvement opportunities and communicate supplier risks and/or opportunities to 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 to investigate, resolve, and prevent supplier quality issues that 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
Requirements
  • 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
What We Offer

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.

Ultima Genomics is proud to be an equal opportunity workplace and is an affirmative action employer. We provide equal employment opportunity for all applicants and employees. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws. See also Ultima Genomics' EEO Policy and Know Your Rights. If you have a disability or special need that requires accommodation, please let us know by contacting.

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