Senior Quality Engineer – GMP Medical Devices (Bilingual)

FITS, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS, LLC is seeking a Quality Assurance professional to support medical device manufacturing in Puerto Rico. The role emphasizes high standards in inspection, validation, and process control, with a focus on IQ/CSV/OQ/PQ and GMP environments.

You will collaborate with engineering and manufacturing teams to enforce quality systems, perform statistical analyses, and drive continuous improvement while ensuring compliance with FDA and ISO 13485 requirements.

Qualifications

• Bachelor's Degree in Mechanical, Biomedical, Industrial or Chemical Engineering and five years of exposure within the Medical Devices Industry.
• Bilingual: Spanish and English.
• Soft Skills: Excellent teamwork 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.
• 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.

Skills

Bilingual: Spanish and English

Excellent teamwork skills

Customer service oriented

Education

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

Job description

FITS, LLC is seeking a Quality Assurance professional to support medical device manufacturing in Puerto Rico. The role emphasizes high standards in inspection, validation, and process control, with a focus on IQ/CSV/OQ/PQ and GMP environments.

You will collaborate with engineering and manufacturing teams to enforce quality systems, perform statistical analyses, and drive continuous improvement while ensuring compliance with FDA and ISO 13485 requirements.