Quality Engineer

We are seeking a highly motivated Senior Quality Engineer to act as the primary quality interface for customers in the Medical Devices, Healthcare, and Hygiene sectors. The successful candidate will be responsible for ensuring customer satisfaction through effective quality management, complaint handling, problem-solving, change management, customer audits, and continuous improvement initiatives.

This position requires a strong customer-oriented mindset, excellent analytical and communication skills, and proven experience in structured problem-solving methodologies. Knowledge of EDANA standards, customer-specific requirements, and automotive quality methodologies is highly desirable.

Key ResponsibilitiesCustomer Quality Management

• Serve as the primary quality contact for customers in the Medical, Healthcare, and Hygiene sectors.

• Build and maintain strong customer relationships regarding quality performance and expectations.

• Support customer business reviews, quality meetings, and development projects.

• Ensure effective communication and timely resolution of customer quality concerns.

• Monitor customer quality KPIs and lead improvement initiatives when required.

Customer Complaints and Problem Solving

• Lead investigations of customer complaints, claims, and non-conformities.

• Utilize structured problem-solving methodologies such as 8D, Root Cause Analysis, and CAPA to identify and eliminate root causes.

• Prepare and communicate technical reports, corrective action plans, and responses to customers.

• Coordinate cross-functional teams to ensure timely and effective issue resolution.

• Verify the effectiveness of corrective and preventive actions.

Change Management

• Lead and coordinate Change Management activities related to products, specifications, raw materials, manufacturing processes, suppliers, and customer requirements.

• Assess risks and potential impacts of proposed changes on quality, compliance, performance, and customer expectations.

• Ensure customer notification and approval requirements are fulfilled when applicable.

• Coordinate cross-functional teams to implement and validate changes successfully.

• Maintain proper documentation and records within the Quality Management System.

• Verify the effectiveness of implemented changes and drive continuous improvement.

Customer Audits

• Plan, coordinate, and actively participate in customer audits and assessments.

• Act as the primary quality representative during customer audits and site visits.

• Prepare audit documentation, records, action plans, and supporting evidence.

• Manage audit findings, observations, corrective actions, and closure activities.

• Monitor audit performance indicators and implement continuous improvement actions.

• Support customer qualification, requalification, and supplier approval processes.

Continuous Improvement

• Drive quality improvement initiatives focused on customer satisfaction, product quality, and process capability.

• Analyze quality trends, customer feedback, and performance data to identify improvement opportunities.

• Implement preventive measures to reduce recurring issues and enhance process robustness.

• Promote best practices and lessons learned throughout the organization.

Quality Standards and Compliance

• Ensure compliance with customer-specific quality requirements and applicable industry regulations.

• Support compliance with EDANA standards and hygiene industry best practices.

• Participate in Quality Management System activities to ensure alignment with company and customer expectations.

• Collaborate with internal teams to maintain effective quality processes and documentation.

New Product and Project Quality Support

• Participate in product development, qualification, validation, and commercialization activities.

• Support customer approval and qualification processes.

• Review quality risks associated with new products, process changes, and customer requirements.

• Contribute to product quality planning and risk management activities.

QualificationsEducation

• Bachelor’s Degree in Engineering, Quality Management, Materials Science, or a related technical discipline.

Experience

• Minimum of 5 years of experience in Customer Quality, Quality Engineering, or Quality Assurance within manufacturing or industrial environments.

• Experience working with customers in Medical Devices, Healthcare, Hygiene, Personal Care, or other regulated industries.

• Proven experience managing customer complaints and leading structured problem-solving activities.

• Experience supporting and managing customer audits.

• Experience with change management processes in manufacturing environments.

Technical Knowledge

• Strong knowledge of quality tools and methodologies, including:

• 8D Problem Solving

• Root Cause Analysis

• CAPA

• FMEA

• Statistical Analysis

• Risk Assessment

• Knowledge of EDANA standards and hygiene industry requirements.

• Familiarity with automotive quality methodologies, including:

• APQP

• PPAP

• MSA

• SPC

• IATF 16949 principles

• Knowledge of ISO 9001 and Quality Management Systems.

• Understanding of customer-specific quality requirements and audit expectations.

• Experience in Change Management and quality risk assessment.

Key Competencies

• Strong customer focus and relationship management skills.

• Excellent analytical and problem-solving capabilities.

• Results-oriented with a proactive and continuous improvement mindset.

• Strong communication, presentation, and negotiation skills.

• Ability to influence and collaborate across functions.

• Effective project and priority management skills.

• High level of ownership, accountability, and resilience.

Languages

• Spanish - Advanced/Native (REQUIRED)

• Professional proficiency in English (written and spoken REQUIRED)

• Additional languages are considered an advantage but not required

What We Offer

• A strategic customer-facing quality position with significant business impact.

• Direct interaction with leading Medical, Healthcare, and Hygiene industry customers.

• Opportunities to lead improvement projects, customer quality initiatives, and audit activities.

• International exposure and professional growth opportunities.

• A collaborative, innovative, and quality-driven work environment.

About the Role

We are looking for a customer-oriented quality professional with extensive experience in regulated industries, strong problem-solving skills, expertise in customer audits and change management, and a solid understanding of EDANA and automotive quality methodologies. The successful candidate will play a key role in strengthening customer confidence, improving product quality, and supporting sustainable business growth.

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