BD

Senior Design Quality Engineer

BD

full-time

Posted on:

Location Type: Hybrid

Location: Brea • California • 🇺🇸 United States

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Salary

💰 $102,000 - $168,200 per year

Job Level

Senior

About the role

  • Supports new product development and product maintenance through Quality engineering skills for medical devices
  • Handles projects and tasks from product inception through product launch and maintenance
  • Ensures products meet quality standards consistent with Corporate and Business Unit policies
  • Develops advanced technological ideas and guides their development into a final product

Requirements

  • Bachelor’s Degree in Engineering or Science related
  • Minimum 5 years of experience supporting design assurance for medical devices
  • Design controls, change controls, risk management, auditing and CAPA experience required
  • Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements
  • Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)
  • Quality Engineering tools, Statistics, Problem Solving
Benefits
  • Valuable, competitive package of compensation and benefits
  • Health insurance
  • 401(k) matching
  • Paid time off
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
quality engineeringdesign assurancerisk managementauditingCAPAstatisticsproblem solving