Senior Quality Assurance Engineer
Danaher Corporation
full-time
Posted on:
Location Type: Office
Location: Miami • Florida • United States
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Job Level
About the role
- Write and conduct IOQ and spreadsheet validations
- Complete PQ, TMV, AQ, and NPSV validations
- Manage process and product non-conformances in line with company procedures
- Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards
Requirements
- Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area)
- 5+ years of experience in the medical device industry
- Familiarity with CFR 21 Part 820 and ISO13485
- Proficiency in Microsoft Excel
- Good working knowledge of computer programming and systems
- Previous experience in PQ, TMV, AQ, NPSV validations (a plus)
- Exposure to Gamp5 or similar regulations (a plus)
- ASQ Certified Quality Engineer (CQE) (a plus)
Benefits
- Comprehensive, competitive benefit programs
- Health care program
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
IOQ validationspreadsheet validationPQ validationTMV validationAQ validationNPSV validationquality management systemsystems automationcomputer programmingregulatory compliance
Certifications
ASQ Certified Quality Engineer (CQE)