Ingeniero de Aseguramiento de Calidad

At Cardinal Health, we develop innovative products and services that make healthcare safer and more productive. Join a growing global company genuinely committed to making a difference for our customers and communities.

• Administers the complete customer complaint process, including complaint intake, initial assessment, investigation assignment, follow-up, documentation, and closure in accordance with established procedures and regulatory requirements.
• Coordinates complaint investigation activities performed by technicians and cross-functional team members.
• Reviews and closes no-sample/no-lot complaints in accordance with applicable procedures.
• Maintains complaint-related quality databases, records, dashboards, and key performance indicators (KPIs), ensuring data accuracy, completeness, and timely updates.
• Provides direct support during FDA, Corporate, TUV, and other applicable regulatory or quality system audits.
• Develops a detailed understanding of internal and external processes that may generate a Complaint and/or CAPA; verifies the accuracy of reported information and ensures that adequate objective evidence is available and properly documented.
• Coordinates the importation, receipt, tracking, and chain of custody of customer complaint samples submitted for investigation.
• Maintains and improves complaint-handling procedures, work instructions, templates, and internal documentation in compliance with corporate requirements, ISO 13485, FDA Quality System requirements, MDSAP, and other applicable regulations.
• Coordinates user training and manages technical and administrative activities associated with electronic complaint-handling and quality management systems.
• Supports customer complaint failure investigations, including unconfirmed failures, using structured root cause analysis and problem-solving tools such as Ishikawa diagrams, 5 Whys, affinity diagrams, fault tree analysis, DOE, and other applicable methodologies.
• Participates in CAPAs associated with customer complaint investigations and provides complaint data, trend information, and investigation evidence as required.
• Completes the inspection, testing, and technical analysis of customer complaint samples received at the site.
• Analyzes, summarizes, reports, and communicates customer complaint status, investigation progress, aging, trends, and KPIs on a weekly, monthly, and quarterly basis.
• Follows up on complaints assigned to the site to ensure investigations and closures are completed accurately and within established timelines.
• Provides Quality Engineering support during failure investigations when functional testing, dimensional analysis, product evaluation, or verification of reported failure modes is required.
• Coordinates activities and ensures compliance with applicable requirements within the Customer Complaints Laboratory.

• Uses electronic complaint-handling systems and/or eQMS platforms to document, route, track, investigate, approve, and close complaints; experience with systems such as TrackWise, Salesforce, SAP, or equivalent tools is preferred.
• Prepares, reviews, and coordinates clear, accurate, and professional customer response letters in English, ensuring alignment with investigation conclusions, regulatory requirements, approved templates, and company communication standards.
• Collaborates with Customer Service, Regulatory Affairs, Manufacturing, Engineering, Quality, and other cross-functional partners to obtain information, communicate investigation findings, and support timely customer responses.
• Assesses complaint information for potential reportability, escalation, adverse event, product quality, safety, or regulatory concerns and promptly communicates such cases to the appropriate functions in accordance with established procedures.
• Performs complaint trending and data analysis to identify recurring failure modes, emerging signals, systemic issues, and opportunities for product or process improvement.

Qualifications

• Bachelor's degree in Engineering, Quality, Science, or a related technical field, or equivalent experience.
• Advanced English proficiency required, including strong written communication skills for technical reports and customer-facing correspondence.
• Minimum of 3 years of experience in the medical device or other highly regulated industry, preferably with direct responsibility for customer complaint handling and investigation.
• Working knowledge of ISO 13485, FDA Quality System requirements, MDSAP, and applicable complaint-handling and post-market surveillance requirements.
• Complaint-handling experience strongly preferred
• Demonstrated knowledge of root cause analysis, investigation, and problem-solving tools.
• Hands-on experience with customer complaint investi