Quality Engineer II

FITS, LLC; Humacao (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

FITS is seeking a Mechanical/Biomedical/Industrial/Chemical Engineer with 3 years in the Medical Devices Industry to join our manufacturing team in Puerto Rico. The candidate will uphold quality standards, support validation activities, and drive process improvements in a GMP/ISO environment.

The role requires bilingual Spanish/English and strong problem-solving, risk assessment, and data analysis skills. Collaboration with engineering, production, and QA is essential to ensure compliant,

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial or Chemical Engineering.
• 3 years of exposure in the Medical Devices Industry.
• Bilingual: Spanish and English.
• Soft Skills: 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 (e.g., Minitab, JMP, Excel, Power BI, SAP).

Responsibilities

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Devises and implements methods for inspecting, testing, and evaluating products and production equipment.
• Designs inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess costs and responsibility for nonconforming products or materials.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, or research.
• Experience with GMP, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
• Knowledge of validation and manufacturing processes (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
• Proficiency in problem-solving, risk assessment, and data analysis tools (FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending).
• Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma and automation/programming experience are preferred.

Skills

Teamwork

Bilingual Spanish/English

Problem solving

Risk assessment

Data analysis

Education

Bachelor's degree in Mechanical or Biomedical or Industrial or Chemical Engineering

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

For Engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, and three (3)years of exposurewithin the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent teamwork skills
• Shift: 1st & 2nd, 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
  • Experience with quality and businesssystems

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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, includingequipment, 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 businesssystems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!