Not specified (assumed to be on-site due to gmp and cleanroom requirements)
Gmp and iso regulated environments
Root cause analysis and capa implementation
Statistical analysis for quality metrics
Thermo Fisher Scientific is seeking a Quality Engineer II in Miami, FL, to ensure compliance with quality standards and regulatory requirements in their manufacturing operations. The ideal candidate will have a background in quality assurance within GMP/ISO regulated environments and will be responsible for driving continuous improvement initiatives and maintaining high product quality standards
Job Summary
Join the Quality Assurance team to ensure compliance with quality standards and regulatory requirements across manufacturing operations.
Collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions.
Contribute to a global mission of making the world healthier, cleaner, and safer by developing solutions for critical challenges.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Quality Engineer II in Miami, FL, to ensure compliance with quality standards and regulatory requirements in their manufacturing operations. The ideal candidate will have a background in quality assurance within GMP/ISO regulated environments and will be responsible for driving continuous improvement initiatives and maintaining high product quality standards.
Skills & Requirements
Must-have
GMP and ISO regulated environments
Root cause analysis and CAPA implementation
Statistical analysis for quality metrics
Cleanroom environment adherence
Internal audit and regulatory inspection support
Nice-to-have
ISO 13485/FDA Lead Auditor certification
ASQ CQE or CQA certification
TrackWise or SAP QM software proficiency
Cross-functional collaboration skills
Project management and strategic planning
Key Requirements
Bachelor's Degree plus 2 years QA experience in GMP/ISO
Advanced Degree with no prior experience
Life Sciences, Engineering, Chemistry or related field