.**Summary**:Coordinates subordinates in the inspection and/or receiving testing and/or process and finished products, according to established procedures.**Responsibilities**:- Participates/Leads CAPA investigations.- Evaluate and makes analysis of samples received from customers related to Customer Complaints.- Perform investigations and action plans related to the customer complaints and CAPAs.- Works with a multidisciplinary team to identify the root cause of problems, define the necessary actions required to assure corrective and preventative actions are properly implemented and documented.- Ensure that Corrective and Preventive Actions implemented have been effectives.- Participate in the process and product improvement plans.- Participates actively in cost reduction and PPI projects.- Gives support to Quality Assurance & Quality Manager to participate in external audits and support in audit observations (ISO 9001 and ISO 13485 environment)- Coordinates the initiation and closure of internal non conformances (NCMs). Uses of Trackwise System for this process.- Works in the Root Cause Analysis for NCM in the production area.- Participates/Leads internal audits.- May participate in the Management Review as presenter on its area.- Conducts trend analysis and post activities related when a trend is presented.- Originator of Document and Change Control DCOs, ECOs, ECR etc. Uses of Agile System- Originator of Deviations if need it using Trackwise System.- Close relationship with the Quality Supervisor for activities related to product requirements.- Create/perform pFMEAs and updates as needed (ISO 14971).- Develop quality requirements based on drawing and customer requirements.- As need it, will create or update work instructions WIN, procedures SOP, visual aids, FRM, formats, Internal Quality Alerts related to its area.- Create Protocols and perform Test Method Validations, process validations quality matter.- Works to achieve Quality KPEs and Quality Objectives.- Participates/Leads new projects.- Other duties may be assigned, as required.**Education**:- Bachelor's degree in Engineering or Science or equivalent training and /or experience, with focus on Biochemicals, Industrial Engineering and/or Quality Engineering.- Internal auditor desirable- Six Sigma desirable- ASQ Certifications desirable**Experience**:- 5+ year of experience as Quality Engineering.- Injection Molding.- Knowledge: ISO 13485, 21 CFR part 820. (Medical Devices Industry)- Software Systems related, such as Agile, Trackwise, Macola (desirable)- Applications of Statistics, Minitab- Measurement instruments as calipers, micrometers, Vision optical.- Knowledge of Lean manufacturing process.- Hands-on experience in CAPA Process.- Experience with problem-solving techniques such as Fishbone diagram, 8 Step-Method, etc