Sr. Quality Engineer

FITS LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a qualified engineer for a QA/Quality role in the medical devices industry. The candidate will develop and maintain quality standards, validate equipment, and ensure compliance with FDA/ISO requirements, collaborating with engineering and manufacturing teams to drive continuous improvement.

The ideal person has an engineering degree, bilingual Spanish/English, and strong teamwork skills, with experience in equipment validation, quality systems, and change control.

Qualifications

• Bachelor’s degree in engineering field (Mechanical, Biomedical, Industrial or Chemical).
• Bilingual in Spanish and English.
• Strong teamwork and collaboration skills.

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.
• Implements inspection, testing, and evaluation methods for products and equipment.
• Designs or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess product quality and responsibility for non-conforming items.
• Ensures corrective actions meet reliability standards and are well documented.
• May specialize in design, incoming material, production control, or reliability.

Skills

Bilingual: Spanish & English

Teamwork

Education

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

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, and five(5)years of exposurewithin the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent teamwork skills
• Shift: 1st and according to business needs.
• Experience in:
  • Equipment & Process Validation
  • Quality Systems & Change Control
  • Regulatory Compliance & Manufacturing Change Management

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.
• Expertise in developing, reviewing, approving and executing validation strategies and deliverables associated with equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments.
• Strong knowledge of Quality Management Systems (QMS), including change control, risk management, nonconformance investigations, and assessment of quality impact resulting from equipment, facility, and process changes.
• Experience evaluating regulatory impact associated with facility modifications, equipment relocations, and process changes, ensuring compliance with FDA, ISO 13485, and applicable global regulatory requirements.

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?