Senior Design Quality Specialist

BAXTER HEALTHCARE PTY AUS

Base: $88,000 - $121,000 annually; bonus: eligible...
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3-5 years engineering or quality experience
Solid understanding of fda regulations
Knowledge of design controls and change control
** Baxter Healthcare is seeking a Senior Design Quality Specialist to provide quality support for their Clinical Nutrition Medical Device disposables platform. The ideal candidate should possess 3-5 years of relevant engineering or quality experience in the medical device industry, alongside familiarity with FDA regulations and quality management systems. This role offers a competitive salary and comprehensive benefits package, focusing on fostering a collaborative and purpose-driven workplace culture. **

Job Summary

  • This position provides design quality support to ensure compliance of DHF deliverables for safe and effective medical devices.
  • The role involves conducting complaint trend analysis, facilitating project teams, and supporting internal and external audits.
  • Baxter offers comprehensive benefits including medical coverage starting day one, a 401(k) plan with matching, and up to 35 days of paid time off.

Matching Summary

Match Score: 75

** Baxter Healthcare is seeking a Senior Design Quality Specialist to provide quality support for their Clinical Nutrition Medical Device disposables platform. The ideal candidate should possess 3-5 years of relevant engineering or quality experience in the medical device industry, alongside familiarity with FDA regulations and quality management systems. This role offers a competitive salary and comprehensive benefits package, focusing on fostering a collaborative and purpose-driven workplace culture. **

Salary

Base: $88,000 - $121,000 annually; Bonus: Eligible for discretionary bonuses; Benefits: Comprehensive health, dental, 401(k), and PTO included

Skills & Requirements

Must-have

  • 3-5 years engineering or quality experience
  • Solid understanding of FDA Regulations
  • Knowledge of Design Controls and Change Control
  • Familiarity with Minitab software
  • Experience with DMAIC investigation tools

Nice-to-have

  • Prior medical device product development experience
  • Cross-functional team collaboration skills
  • Ability to organize technical information independently
  • Mentorship capabilities for QMS requirements

Key Requirements

  • 3-5 years related engineering/science/quality experience
  • Authorization to work in the U.S. without sponsorship
  • Basic understanding of DMAIC tools
  • Familiarity with Minitab required

Work Rights

Must be authorized to work in the U.S.

Tailored Resume

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