Quality Engineer II

Flexible & Integrated Technical Services, LLC•Humacao, PR

About The Position

This role is for Engineering services in the Manufacturing area. The ideal candidate will have a Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, and three (3) years of exposure within the Medical Devices Industry. Bilingual in Spanish and English is required, along with excellent teamwork skills. The position involves working 1st & 2nd shifts, and according to business needs. Experience in FDA/ISO-regulated manufacturing environments, knowledge of validation and manufacturing processes, proficiency in problem-solving, risk assessment, and data analysis tools, and experience with quality and business systems are essential. The company culture emphasizes treating everyone like family, fostering innovation, and delivering top-quality results.

Requirements

Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering
Three (3) years of exposure within the Medical Devices Industry
Bilingual: Spanish and English
Excellent teamwork skills
Experience in FDA/ISO-regulated manufacturing environments
Knowledge of validation and manufacturing processes
Proficiency in problem-solving, risk assessment, and data analysis tools
Experience with quality and business systems
Experience in 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

Nice To Haves

Lean Six Sigma certification
Automation/programming experience

Responsibilities

Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment.
Conducts quality assurance tests.
Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research.
Experience in 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) and strong communication, collaboration, continuous improvement, and critical-thinking skills.