Sr. Quality Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR

8d•Onsite

About The Position

This role is for engineering services in the Manufacturing area. The ideal candidate will have a Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, with five (5) years of experience in the Medical Devices Industry. Bilingual proficiency in Spanish and English is required, along with excellent teamwork skills. The position operates on a 1st shift, with flexibility according to business needs. Key areas of experience include Equipment & Process Validation, Quality Systems & Change Control, Regulatory Compliance & Manufacturing Change Management. The company culture emphasizes treating everyone like family, fostering innovation, and delivering top-quality results.

Requirements

Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering
Five (5) years of exposure within the Medical Devices Industry
Bilingual: Spanish and English
Excellent teamwork skills
Experience in Equipment & Process Validation
Experience in Quality Systems & Change Control
Experience in Regulatory Compliance & Manufacturing Change Management

Nice To Haves

Customer service skills
Innovative mindset

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.