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Quality Assurance Engineer I
Danaher CorporationQuality Assurance Engineer I at Beckman Coulter Diagnostics ensuring compliance to regulatory standards and driving continuous improvement in instrument manufacturing processes.
About the role
Key responsibilities & impact- Ensure compliance to the Quality System procedures, corporate policies, and global regulations (21CFR820, ISO13485, ISO14971)
- Non-conformance and planned deviations SOP / DMR updates through change orders
- Equipment qualifications / validations
- Stop ships / containment
- Identify continuous improvement opportunities and utilize DBS to drive improvements cross-functionally with development, technical operations, and manufacturing to ensure quality
- Reduce defects/ non-conformances
- Increase productivity
- Reduce operator cycle time
Requirements
What you’ll need- Bachelor’s degree in engineering (i.e. Mechanical or Electrical)
- 0-2+ years' relevant experience
- CQE preferred
- Experience in the medical device industry preferred
Benefits
Comp & perks- Health care program
- Paid time off
- Medical/dental/vision insurance
- 401(k)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality system procedurescomplianceequipment qualificationsvalidationsnon-conformancedeviationscontinuous improvementdefect reductionproductivity increasecycle time reduction
Soft Skills
cross-functional collaborationproblem-solvinganalytical thinking
Certifications
CQE