Sr Quality Engineer
On-siteHumacao, Humacao, Puerto Rico
Job Summary
Develop and implement methods for inspecting, testing, and evaluating products and production equipment while maintaining compliance with FDA, ISO, and GMP standards. Perform statistical analysis using tools like Minitab, JMP, and Power BI to drive continuous improvement and risk management. Collaborate with engineering and manufacturing functions to ensure quality standards are in place across design, production control, and reliability. Act as a mentor to colleagues and direct lower-level professionals on assigned projects. Requires a Bachelor's or Master's degree in engineering with four years of experience in regulated manufacturing environments.
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
- Lean Six Sigma certification
- Automation/programming experience
- University Degree
- Minimum of 4 years of relevant experience
Desired Qualifications
- Master's degree in Mechanical, Industrial, Electrical Engineering, or related field
- Practical knowledge of project management
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