Customer Quality Engineer

Job Description Serve as Primary Customer Contact in which the individual will respond to direct customer questions, customer notifications of issues/deviations, consistently give updates to on-going issues, and maintain/update customer Quality Agreements. Independently review, provide counsel, and/or approve customer complaints from initial intake through final resolution, ensuring timely investigation, root cause analysis, implementation of corrective and preventive actions (CAPA), and effective communication with customers and internal stakeholders. Perform review and approval of validations, qualifications and certificates of analysis. Independently evaluate, process, and implement change requests using formal change control processes, ensuring appropriate risk assessment, cross-functional alignment, documentation, and regulatory compliance. Perform comprehensive product and process risk assessments utilizing established quality risk management methodologies (e.g., FMEA, risk matrices) and implement appropriate mitigation and monitoring strategies. Plan, support, and actively participate in internal, customer, and regulatory audits by preparing documentation, facilitating audit activities, responding to audit observations, and ensuring timely completion of corrective actions. Build and maintain effective working relationships with cross-functional teams including Production, Technical Services (TS), Customer Services (CS), Engineering, Supply Chain, Plant Management, and external stakeholders such as customers, suppliers, and regulatory representatives. Lead or support the implementation of new products, manufacturing processes, technology transfers, continuous improvement initiatives, and other strategic projects while ensuring compliance with quality, cost, and timeline objectives. Maintain compliance with applicable international quality standards, regulatory requirements, customer-specific requirements, occupational health and safety regulations, and internal company policies, procedures, SOPs, and work instructions. Create, maintain, and continuously update Product Master Files (PMFs) and related technical documentation, ensuring all product, process, and transfer changes are accurately reflected and controlled. Monitor quality performance metrics, identify trends through statistical analysis, and recommend process improvements that enhance product quality, manufacturing efficiency, and customer satisfaction. Support continuous improvement initiatives by applying Lean Manufacturing, Six Sigma, or equivalent quality improvement methodologies where applicable. Prepare technical reports, quality summaries, management presentations, and customer communications to support decision-making and regulatory compliance. Qualifications Bachelor's degree or higher in Quality Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline. Equivalent technical education combined with significant relevant professional experience will also be considered. Minimum of five (5) years of progressive experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or a comparable technical quality management role within a regulated manufacturing environment. Demonstrated experience managing customer complaints, quality investigations, non-conformance management, change control, and corrective and preventive action (CAPA) processes. Strong knowledge of manufacturing processes, production technologies, product lifecycle management, and process validation principles. Comprehensive understanding of Quality Management Systems (QMS) for Medical Devices and applicable quality standards, including implementation and continuous improvement of quality processes. Experience participating in or supporting internal, external, customer, and regulatory audits. Strong working knowledge of quality tools and statistical methodologies, including Statistical Process Control (SPC), Process Capability Analysis, Root Cause Analysis, FMEA, 8D, Fishbone Diagram, Pareto Analysis, and other structured problem-solving techniques. Proficiency with Microsoft Office Suite and experience using Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management software, and other manufacturing information systems. Additional Information Knowledge obtained by technical or scientific study or equivalent technical education (e.g. mechanical technician, injection molding technician) with professional experience in the medical/pharmaceutical industry. Solid professional experience in the field of Quality for at least 5 years. #J-18808-Ljbffr