Quality Systems Engineer (AR)
Grupo TECMA
Qualifications: Education: Bachelor’s Degree in Engineering, Quality, or a related technical field. Experience: 1–5 years of experience in a quality or regulatory role in manufacturing or regulated industries. Formal training as ISO lead auditor (ISO 9001 or equivalent). Experience participating in at least one external audit by a customer, registrar, or regulatory agency. Familiarity with industry standards (ISO 9001, ISO 13485, IATF 16949, AS9100) and general quality tools. Technical Skills: Good understanding of QMS principles, document control, nonconformance/CAPA systems. Ability to interpret and apply quality system requirements. Proficient in Microsoft Office and QMS software (e.g., MasterControl, Arena, or similar platforms). Strong organizational and written communication skills. Language: Proficiency in English (written and verbal). Preferred: Experience in electronics manufacturing or medical device industry. Familiarity with risk management tools (e.g., FMEA, 5 Whys, Fishbone). Working knowledge of ISO 13485, FDA 21 CFR 820, or related standards
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