Quality Assurance Engineer

**About the role**The Quality Assurance Engineer will have a key position to support production as main leader, assuring the compliance for regulations, standards, QMS internal procedures on new projects, process improvements, validation & re-validations, risk management and customer complaints investigations.In relation to quality issues from nonconforming material, maintain quality indicators and internal deviations to coordinate and perform needed activities for a good follow up of a quality system.**Key responsibilities**Process Control related- Assure the process control is followed during product manufacturing. Monitor the process output and organize activities to meet and maintain the product quality standards.- Support the quality system by being focused on adequate handling of non-conformity activities, corrective and preventive actions.- Define a classification of all Non-Conformities based upon the risk.- Coordinate and lead the investigation / root cause, with the team member involved (maintenance, production, logistic, engineering, etc.).- Review, update and develop procedures, instructions, quality specification as needed.- Collect and review the objective evidence to complete the investigation and therefore the correct NC closure and assure the effectiveness of the actions established.- Follow up the QA roll as per NC procedure require (for instance, Originator, Owner, Quality Reviewer, Approver, etc.) as needed.- Monitor the process KPIs (PPMs, NCs, etc) and present any trending to the NCRB and take actions if needed.- Make sure the actions are being supported or referenced to the quality system.- Promote ideas for continuously improvement of Quality with the end achieve the fulfillment across of the systems simplicity.- Support at several areas where his/her experience and technical knowledge about the problem can be usefully (production, microbiology, systems, etc).- Perform internal process audits, when required.- Keep communication with other departments MX / DK in relation to any quality problem.- Create Quality alerts and Provide support on the definition of quality criteria, when needed.Projects & Validation related- Participate in development teams having as main responsibility the quality and fulfillment with the regulations or other applicable standards.- Update and develop PFMEcA from the Risk management related with changes from projects, internal inputs, etc.- Support on the risk assessment preparation, when needed.- Support on the development of verification and validation of products.- Establish and maintain VMP (Validation Master Plan) for re-validation of process equipment, including validation history and assure it is approved by and communicated to relevant areas.- In cooperation with the Production and Eng Department ensure resource planning for re-validation activities.- Filling of validation documentation is following procedures and applicable regulations.- Review of acute maintenance on process equipment for evaluation of need for re-validation according to document .- Management of software validations in all systems applied, in collaboration with project leader- Collaborate on validation of molds and molding machines providing the support as Quality Engineering- To comply with the company quality policy.- Support on review IQ, OQ and PQ validations of test equipment validation.Safety, Health, and Environment Responsibilities- Comply with safety, health and environmental policy, procedures established by the EHSMS.- Maintain applicable documented information related to the EHSMS up to date.- Participate in committees, training's, and awareness, to ensure proper competency of their position if applicable.- Be aware of and support compliance with applicable significant environmental aspects and associated significant environmental impacts.- Understand EHS risk and legal requirements relating to job responsibilities and appropriate requirements.- Execute job responsibilities with professional care and in compliance with legal requirements and internal standards without compromising the safety of self and others.- Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as soon as they are identified (e.g. spills).- Help drive continuous performance improvement in EHS areas, recommending potential improvements to responsible management.- Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the intended results of their activities.**Requirements**:- Bachelor’s degree (Mechanical, Electronic, Industrial area or similar education)- Min. 3 years’ experience on Engineering areas- Strong Experience on handling of QMS (Quality management system)- Strong Experience on Quality Control Charts (histogram, pareto, process capability calculations, controls charts, etc)- Strong Experience on Quality Manag