## Ingeniero de Calidad De QuejasApplylocations: Mexico-Tijuana 9 Surtime type: Full timeposted on: Posted Todayjob requisition id: **********At Cardinal Health, we develop innovative products and services that make healthcare safer and more productive.Join a growing integral 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 *****, 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 systemssuch 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 *****, FDA Quality System requirements, MDSAP, and applicable complaint-handling and post-market surveillance requirements.
* Demonstrated knowledge of root cause analysis, investigation, and problem-solving tools.
* Hands-on experience with customer complaint investigations, complaint documentation, sample evaluation, and complaint closure in an electronic complaint management or eQMS system.
* Experience drafting and reviewing technical investigation summaries and customer response letters in English.
* Ability to analyze complaint data, identify trends, manage multiple investigations, and meet established quality and regulatory timelines.
* Strong cross-functional communication, technical writing, organization, and attention to detail.
*Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
*#J-*****-Ljbffr

📌 Ingeniero De Calidad De Quejas (Tijuana)
🏢 Cardinal Health
📍 Tijuana