Mariela Martinez
About Mariela Martinez
Mariela Martinez is a Sr. Quality Systems Specialist with extensive experience in quality assurance and compliance across various pharmaceutical and medical device companies. She has held multiple positions in organizations such as Pfizer, Thermo Fisher Scientific, and BD, and holds a Bachelor's degree in Chemistry and an MBA in Technology Management.
Work at Heru
Mariela Martinez serves as a Senior Quality Systems Specialist at Heru, a company recognized for its advancements in wearable diagnostic and vision augmentation technologies. She has held this position since 2021, contributing to the company's commitment to quality and compliance in its innovative products. Her role involves ensuring that quality systems meet industry standards and regulatory requirements.
Previous Experience
Prior to her current role at Heru, Mariela Martinez accumulated extensive experience in quality assurance and management across various organizations. She worked at Continental Services Group, Inc. as a Quality Assurance Internal Auditor from 2011 to 2013. She also held positions at Thermo Fisher Scientific, Boston Scientific, Pfizer, Apotex Inc., BD, and DuPont Pharmaceuticals, where she developed her expertise in quality systems and compliance.
Education and Expertise
Mariela Martinez earned her Bachelor's degree in Chemistry from the University of Puerto Rico-Mayaguez. She furthered her education by obtaining an MBA in Technology Management from the University of Phoenix. Her expertise encompasses manufacturing operations for various pharmaceutical products, as well as auditing techniques, aseptic practices, and document control.
Certifications
Mariela Martinez holds several professional certifications that enhance her qualifications in quality systems. She is an ISO 9001:2015 Internal Quality Systems Auditor and has earned the ASQ-Certified Quality Auditor and ASQ-Certified Quality Improver Associate certifications. These credentials reflect her commitment to maintaining high standards in quality assurance and improvement.
Specializations
Mariela specializes in several key areas within quality systems, including internal and external audits, documentation review and approval, investigations, and Corrective and Preventive Actions (CAPA). Her focus on aseptic practices and compliance in manufacturing operations for parenteral and lyophilized products, as well as transdermal and cell culture products, underscores her comprehensive knowledge in the field.