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Senior Quality Supplier Engineer at Zenflow, Inc. · South San Francisco, CA · Joined
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ZI

Senior Quality Supplier Engineer

Zenflow, Inc. · South San Francisco, CA · Just now · 0 applicants
NewOn-siteFull-timeSenior
Pay
$120k–$135kListed
Workplace
On-site
Job type
Full-time
Level
Senior
Source: jobright · Posted by joined-scrapper

About the role

Senior Quality Supplier Engineer to establish and improve the supplier quality program for a medical device company commercializing a minimally invasive urologic device. The role ensures externally sourced components meet quality, safety, and regulatory requirements while supporting broader quality system activities.

What you’ll do

  • Establish and improve supplier quality program
  • Ensure externally sourced components meet quality, safety, and regulatory requirements
  • Conduct supplier audits per ISO 13485/FDA QSR
  • Manage Supplier Corrective Action Requests (SCARs)
  • Support broader quality system activities
  • Author audit-ready quality documentation

What you’ll need

  • Bachelor's degree in Engineering, Materials Science, Biomedical Engineering, or related technical discipline
  • Minimum 5+ years of quality engineering experience in medical device with focus on supplier quality
  • Demonstrated experience conducting supplier audits (ISO 13485/FDA QSR) and managing SCARs
  • Proficiency with quality tools including FMEA, SPC, 8D, root cause analysis, and sampling plans
  • Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable standards
  • Experience building or significantly improving a supplier quality program in a small to mid-size medical device company

Original job description

Zenflow, Inc. is a medical device company developing treatments for urinary obstruction. The Senior Quality Supplier Engineer establishes and improves the supplier quality program as Zenflow commercializes its product, while supporting broader quality system activities and ensuring externally sourced components and materials meet quality, safety, and…

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