Senior Quality Assurance Engineer

Danaher Corp

Indianapolis, IN, US
Not specified; not specified; comprehensive benefi...
Iso 9001 & iso 13485 standards knowledge
21 cfr part 820 & eu mdr/ivdr regulations
Bachelor's degree in engineering or science
The Senior Quality Assurance Engineer is responsible for owning quality processes in an instrument manufacturing environment and guiding cross-functional teams through Beckman's quality management system requirements

Job Summary

  • The Senior Quality Assurance Engineer is responsible for owning quality processes in an instrument manufacturing environment and guiding cross-functional teams through Beckman's quality management system requirements.
  • This role involves monitoring key quality metrics such as First-Pass Yield and Defect Per Unit to ensure high product quality and identify process improvement opportunities.
  • Candidates will work within a culture of belonging at Danaher, leveraging the Danaher Business System to innovate at the speed of life and save lives through diagnostics and biotechnology.

Matching Summary

The Senior Quality Assurance Engineer is responsible for owning quality processes in an instrument manufacturing environment and guiding cross-functional teams through Beckman's quality management system requirements.

Salary

Not specified; Not specified; Comprehensive benefits including health care and paid time off

Skills & Requirements

Must-have

  • ISO 9001 & ISO 13485 standards knowledge
  • 21 CFR Part 820 & EU MDR/IVDR regulations
  • Bachelor's Degree in engineering or science
  • 5+ years experience in quality systems
  • Cross-functional team leadership skills

Nice-to-have

  • Process Validation strategy development
  • Six Sigma and DMAIC methodology
  • Statistical Process Control expertise
  • Oracle ERP and IQVIA eQMS experience
  • PFMEA and Design of Experiment tools

Key Requirements

  • Bachelor's Degree in engineering or related field
  • 5+ years experience in engineering/manufacturing/quality
  • Working knowledge of ISO 9001 & ISO 13485
  • Regulatory compliance with 21 CFR Part 820
  • Ability to lift up to 40 pounds occasionally

Work Rights

Not specified

Tailored Resume

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