CNV Sr Quality Engineer

Key Responsibilities Champions compliance with applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support during internal and external audits. Conducts investigation, bounding, records documentation, review and approval of non-conformances, CAPAs and customer complaints. Raises quality issues as appropriate. Accountability for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. Analyzes/reviews effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality. Represents as a Subject Matter Expert (SME). Supports or leads in developing validation strategies. Approves IQ, OQ, PQ, TMV or Software Validation. Partners with Global Supply Chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management, and the investigation/correction of process failures when needed. Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Documents, justifies, reviews or analyzes whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs. Qualifications Education A Bachelor’s degree or equivalent in Engineering or related scientific field is required. Experience and Skills Required A minimum of four (4) years of relevant professional work experience in the Medical Devices industry. Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR). Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Experience with CAPAs non-conformances, audits, and process validation. Strong trending and data analysis skills. Troubleshooting expertise. Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance. Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results. Preferred Process Excellence / Six Sigma Certification or equivalent. Other This position may require up to 10% of domestic or international travel. Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws. By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application. #J-18808-Ljbffr