Customer Quality Engineer

About the role

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.

Responsibilities

• 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.
• 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.

Requirements

• 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.

Qualifications

• 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.