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- 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 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.
- Experience with products and processes, specifically process test method validation
- Strong cross-functional communication, technical writing, organization, and attention to detail.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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