(Senior) QA Engineer in a leading European fintech company simplifying international payments. Collaborating with teams to ensure high - quality software testing and QA processes.
About the role
- Senior Quality Assurance Engineer in Miami, specializing in validation deliverables for Beckman Coulter Diagnostics. Collaborating within an environment ensuring impeccable compliance in the medical device industry.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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