Qa Engineer 2

Dexcom Inc

Not specified; not specified; comprehensive benefi...
Supplier quality management system maintenance
Conducting supplier and regulatory audits
Knowledge of iso 13485 and 21cfr part 820
The Supplier Quality department ensures externally sourced components meet stringent medical industry quality and regulatory standards to guarantee patient safety

Job Summary

  • The Supplier Quality department ensures externally sourced components meet stringent medical industry quality and regulatory standards to guarantee patient safety.
  • This role involves maintaining the supplier quality management system, conducting audits, and providing quality guidance to cross-functional departments.
  • Candidates will have the opportunity to influence key quality processes, strengthen supplier partnerships, and support the development of safe and effective medical products.

Matching Summary

The Supplier Quality department ensures externally sourced components meet stringent medical industry quality and regulatory standards to guarantee patient safety.

Salary

Not specified; Not specified; Comprehensive benefits program including tuition reimbursement

Skills & Requirements

Must-have

  • Supplier quality management system maintenance
  • Conducting supplier and regulatory audits
  • Knowledge of ISO 13485 and 21CFR Part 820
  • Experience with DFMEA and PFMEA methodologies
  • Proficiency in structured problem-solving tools

Nice-to-have

  • Six Sigma and Lean manufacturing techniques
  • Training and guidance for junior engineers
  • Hands-on experience with molding and SMT processes
  • Good Documentation Practice (GDP) knowledge
  • Travel availability for international supplier visits

Key Requirements

  • Understanding of ISO 13485 or regulated quality systems
  • Experience with APQP, PPAP, SPC, MSA, and FMEA
  • Manufacturing process knowledge preferred (molding, metal processing, SMT)

Work Rights

Not specified

Tailored Resume

Cover Letter