Customer Quality Engineer

• 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 :

• Bachelors 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.
 

Remote Work :

No

Employment Type :

Full-time