Quality Engineer I

FITS LLC; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC in Humacao, PR is seeking a quality-focused Engineer to support manufacturing and medical devices quality activities. You will work across engineering and production to maintain standards, perform tests, and drive continuous improvements.

The role requires a Bachelor’s degree in engineering and 3 years in the Medical Devices Industry, with bilingual Spanish/English communication and strong teamwork skills. Shift coverage includes 1st and 2nd shifts as needed.

Qualifications

• Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering and three years exposure in Medical Devices Industry.
• Bilingual Spanish and English.
• Soft Skills: Excellent teamwork skills.
• Shift: 1st & 2nd Shift as needed.
• Experience in manufacturing process and quality activities; investigations, validation deliverables, risk assessments, and product/process performance monitoring.

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 or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess costs and responsibility for non-conforming products.
• Ensures corrective actions meet reliability standards and are documented per requirements.
• Specializes in areas like design, incoming material, production control, product evaluation and reliability as needed.

Skills

Bilingual English/Spanish

Teamwork

Quality assurance

Statistical analysis

Problem solving

Education

Bachelor’s degree in Mechanical / Biomedical / Industrial / Chemical Engineering

Tools

Validation deliverables

Risk assessments

Process monitoring

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 Shift and according to business needs.
• Experience in:
  • Manufacturing process and quality activities
  • Investigations, validation deliverables, risk assessments, and product/process performance monitoring.

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.

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!

Are you the Next Piece?