.JOB SUMMARY*The Associate Engineer plans and provides support to engineering projects or studies. Applies engineering principles and practices within the assigned areas. Can coordinate and direct personnel activities of technical support and is responsible for the technical development of the personnel assigned. The quality engineer associate will use quality engineering tools and practices for the effective and efficient development of transfers and product/processes maintenance in the complete life cycle of the product. The holder of this position will also use his/her abilities of investigation and problem resolution to improve and maintain the products/processes that are aligned with the quality and global business vision. He/she will use the appropriate risk management to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business processes.DUTIES & RESPONSIBILITIES*Revision/analysis of the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.Revises/analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc., including providing support during internal and external audits.Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).Responds to internal or external audit observations related to the function of quality engineering.Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audits results of the area to ensure that the corrective and preventive actions are adequate.Conducts or supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applies.Supports the analysis of the products related to customer complaints, to determine failure modes.Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.Analyzes/revises the effectiveness of preventive and corrective actions.Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level
