Customer Quality Engineer

Job Description

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• 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.
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• 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.
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• Perform review and approval of validations, qualifications and certificates of analysis.
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• Independently evaluate, process, and implement change requests using formal change control processes, ensuring appropriate risk assessment, cross-functional alignment, documentation, and regulatory compliance.
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• 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.
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• 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.
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• 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.
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• 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.
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• 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.
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• 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.
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• Monitor quality performance metrics, identify trends through statistical analysis, and recommend process improvements that enhance product quality, manufacturing efficiency, and customer satisfaction.
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• Support continuous improvement initiatives by applying Lean Manufacturing, Six Sigma, or equivalent quality improvement methodologies where applicable.
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• Prepare technical reports, quality summaries, management presentations, and customer communications to support decision-making and regulatory compliance.
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Qualifications:
Qualifications

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• 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.
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• 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.
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• Demonstrated experience managing customer complaints, quality investigations, non-conformance management, change control, and corrective and preventive action (CAPA) processes.
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• Strong knowledge of manufacturing processes, production technologies, product lifecycle management, and process validation principles.
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• Comprehensive understanding of Quality Management Systems (QMS) for Medical Devices and applicable quality standards, including implementation and continuous improvement of quality processes.
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• Experience participating in or supporting internal, external, customer, and regulatory audits.
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• 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.
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• 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.
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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.
nSolid professional experience in the field of Quality for at least 5 years.