Quality Engineer II
On-siteHumacao, Humacao, Puerto Rico
Humacao, Humacao, Puerto RicoOn-siteFull TimeDoctorate Or Professional Degree
Full TimeDoctorate Or Professional Degree
Job Summary
Develop and implement methods and procedures for inspecting, testing, and evaluating products and production equipment while maintaining compliance with FDA/ISO-regulated manufacturing environments. Perform statistical analysis using tools like Minitab, JMP, and Power BI to drive risk assessment, capability analysis, and process improvements. Collaborate with engineering and manufacturing functions to ensure quality standards are in place, manage CAPA, nonconformance, and change control, and mentor lower-level specialists on specialized knowledge.
Required Qualifications
- Bachelor's degree in Mechanical, Industrial, Electrical Engineering, or related field
- Experience in FDA/ISO-regulated manufacturing environments
- GMP compliance
- Inspection readiness
- ISO 13485
- CAPA
- Nonconformance management
- Change control
- Document control
- Risk management
- Knowledge of validation and manufacturing processes
- Equipment validation
- Process validation
- Product validation
- Software validation
- IQ/OQ/PQ
- Risk-based validation
- Manufacturing controls
- Proficiency in problem-solving
- Risk assessment
- Data analysis tools
- FMEA
- 5 Whys
- Fishbone
- SPC
- DOE
- Capability analysis
- Trending
- Process monitoring
- Experience with quality and business systems
- Minitab
- JMP
- Excel
- Power BI
- SAP
- Strong communication skills
- Collaboration skills
- Continuous improvement skills
- Critical-thinking skills
- Engineering bachelor degree
- 2 years experience
Desired Qualifications
- Master's degree in Mechanical, Industrial, Electrical Engineering, or related field
- Lean Six Sigma certification
- Automation/programming experience
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