JT371 - SR QUALITY ENGINEER
On-siteHumacao, Humacao, Puerto Rico
Job Summary
Develop and maintain quality standards, protocols, and procedures for processing materials into finished products. Collaborate with engineering and manufacturing teams to ensure compliance with FDA, ISO, and GMP regulations. Design inspection mechanisms, conduct quality assurance tests, and perform statistical analysis to assess product accuracy and determine responsibility for nonconformances. Implement corrective measures, manage change control, and oversee incoming material, production, and reliability quality. Specialize in areas such as design validation, process monitoring, and risk management using tools like FMEA and SPC. Requires Bachelor's degree in engineering, experience with IQ/OQ/PQ validation, and proficiency in Minitab, JMP, and SAP. Available for 1st and 2nd shifts.
Required Qualifications
- Bachelor's or Master's degree in Mechanical, Industrial, Electrical Engineering, or related field
- 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 and 2 shift
Desired Qualifications
- Lean Six Sigma certification
- automation/programming experience
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