Quality - Sr Quality Engineer

ViantFremont, CA

About The Position

This role is for a Sr. Quality Engineer responsible for various quality assurance tasks within a manufacturing environment. The position involves managing non-conformances, customer complaints, creating reports, participating in improvement projects, and ensuring product quality through validations and audits. The role also requires customer interaction and leadership responsibilities.

Requirements

  • Bachelor's Degree or equivalent experience
  • 7–10 years in Quality or related engineering roles within manufacturing environments
  • Ability to lead root cause analysis with cross‑functional teams and drive corrective/preventive actions.
  • Proficiency analyzing data (e.g., in Excel; exposure to Minitab preferred) to inform decisions and reports.
  • Direct experience producing validation reports and translating execution results into clear documentation.
  • Strong time/task management, responsiveness, proactive ownership, and ability to work with changing priorities.
  • Experience in medical device manufacturing; or other broader manufacturing such as plastics, chemicals, or polymer environments.
  • Proficient with math, statistics, and reading comprehension.
  • Proficient with computer skills (Microsoft Office, etc.)
  • Basic understanding of QMS
  • Solid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.)
  • Functional Quality statistical knowledge (AQL, sampling, etc.)
  • Proficient with QMS
  • Strong leadership abilities
  • Capable of independent project management

Nice To Haves

  • Exposure to Minitab preferred

Responsibilities

  • Open, investigate, and close NCRs.
  • Open, investigate, and close complaints.
  • Create metric reports as assigned.
  • SPC Monitoring
  • Participating in CAPA Projects
  • Participate in validation & measurement capability projects.
  • Update procedures as required.
  • Identify and perform continuous improvement projects.
  • Product line ownership
  • Execute validations.
  • Create control plans and PFMEAs.
  • Perform Internal Audit
  • Perform Supplier Qualification and audits.
  • Customer-facing role, running Drumbeat customer meetings.
  • Leadership role, direct reports of Inspectors or Technician
  • Owner of Critical Quality Subsystems
  • Act as SME in regulatory inspections.

Benefits

  • Medical, dental, and vision benefits
  • Company-paid life insurance and disability benefits
  • Generous Paid time off and 10 paid Holidays
  • 401k Plan with Company Match
  • Tuition Reimbursement
  • Voluntary Universal Life and Long-Term Care
  • Voluntary Legal Plan
  • Pet Insurance
  • Home Ownership Program
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