JT370 - QUALITY ENGINEER II
On-siteHumacao, Humacao, Puerto Rico
Job Summary
Develop and maintain quality standards and protocols for processing materials into finished products. Collaborate with engineering and manufacturing teams to devise inspection methods, specify testing mechanisms, and conduct statistical analysis for nonconformance. Ensure corrective measures meet reliability standards while maintaining documentation compliance with FDA/ISO regulations. Specialize in areas such as design, production control, or reliability to improve manufacturing processes. Requires a Bachelor's or Master's degree in engineering, 2+ years of experience, and proficiency in tools like FMEA, SPC, and SAP. Available for 1st shift.
Required Qualifications
- 2+ years of related experience
- Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management
- Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls
- Proficiency in problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring
- Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP)
- strong communication, collaboration, continuous improvement, and critical-thinking skills
- Availability for 1st shift
Desired Qualifications
- Bachelor's or Master's degree in Mechanical, Industrial, Electrical Engineering, or related field preferred
- Lean Six Sigma certification
- automation/programming experience
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