Quality Engineer I

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

Job summary

FITS, LLC in Puerto Rico is seeking a Quality Engineer to contribute to the manufacturing quality system for our medical devices clients. The role focuses on developing, applying, and maintaining quality standards and protocols for processing materials into finished products, and working closely with engineering and manufacturing teams to ensure compliance.

The candidate will conduct QA tests, perform statistical analyses, and implement corrective actions to meet reliability requirements, while

Qualifications

• Bachelor's degree in engineering and three years of exposure within the Medical Devices Industry.
• Bilingual in Spanish and English.
• Strong teamwork and communication skills.

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.

Skills

Bilingual: Spanish and English

Excellent teamwork skills

Education

Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering

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!