Ma. Carmen Rosales Calderon
About Ma. Carmen Rosales Calderon
Ma. Carmen Rosales Calderon is a Quality System/Affair Regulations Specialist currently working at BD and Teleflex Incorporated in Tijuana and Tecate, Mexico, with over 20 years of experience in Quality Assurance and Manufacturing Production Management.
Current Title and Role
Ma. Carmen Rosales Calderon currently holds the position of Quality System/Affair Regulations Specialist. She is employed at BD as an Audits Specialist and Affair Regulation/Coordinator in Tijuana, Baja California, México. In addition, she works at Teleflex Incorporated as a Quality System/Affair Regulations Specialist in El Descanso, Tecate BC.
Previous Experience
Prior to her current roles, Ma. Carmen Rosales Calderon amassed extensive experience in Quality Assurance and Regulatory Affairs. She worked at Baxter International Inc. as a Sr Quality Systems Engineer for 10 months in Tijuana y alrededores, México. At Teleflex Incorporated, she served as a QA&RA Specialist/Affair Regulations Medical Device for three years in Tecate B.Cfa.Mex. She also held positions at Sumitronics, including QA Regulations ISO/TS-Automotive Manager, and Staff Manager/QA Manager/Automotive Industry/ISO-IATF 16949:2016 Lead Auditor/BSI. Additionally, she has experience as a Sr SQE-Cardiovascular/Biotechnology with Medtronic Hospital Solutions.
Industry Experience
With over 20 years of experience in the maquiladora field, Ma. Carmen Rosales Calderon has a strong background in Quality Assurance and Manufacturing Production Management. Her expertise includes the manufacture of parts by molding and extrusion, Supplier Quality Engineering (SQE), both external and internal audits, and several manufacturing processes. She has maintained compliance with various regulatory standards such as ISO 13485, FDA, ISO 9001, GMP's, CFR, Clean Room 10K class, ANSI, ISO 14000, CE, and UL electronic.
Education and Certifications
Ma. Carmen Rosales Calderon studied at BSI, where she completed FDA Regulation training related to Medical Devices and achieved the LEAD AUDITOR ISO 13485:2016 (19011:2018) certification. She also studied at UABC, specializing in Ciencias Químicas and achieved a Químico degree in Ingeniería Industrial. Additionally, she earned a Green Belt Six Sigma and further qualifications in SQE and CMQ from Universidad Autónoma de Baja California.
Professional Memberships
Ma. Carmen Rosales Calderon is an active member of the American Society of Quality (ASQ), specifically the Tijuana Section 0712. Her involvement with ASQ demonstrates her commitment to ongoing professional development and staying current with best practices in Quality Assurance and Regulatory Affairs.