Quality Specialist, Complaints

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Your Role:
The Quality Specialist, Complaints supports the Quality organization by conducting technical investigations into customer complaints. This role analyzes complaint data, performs root cause analysis, documents investigation findings, and prepares drafts of customer response letters. The Quality Specialist, Complaints also assists in non-conformance documentation and supports CAPA activities.

• Perform documented customer complaint investigations in accordance with FDA 21 CFR Part 820 and ISO 13485 requirements, including review of Device History Records, product history, test data, and customer information.
• Apply structured root cause analysis methodologies such as 5 Whys, Ishikawa/Fishbone to identify potential product, process, or system‑level nonconformities.
• Document complaint investigations clearly, accurately, and contemporaneously to ensure data integrity, traceability, and compliance with quality system requirements.
• Collaborate cross‑functionally with Manufacturing, Engineering, Quality Assurance, and Regulatory Affairs to obtain technical inputs and ensure thorough investigations.
• Draft clear, accurate, and compliant customer response letters that summarize investigation results and applicable corrective or preventive actions, in alignment with regulatory and internal communication standards.
• Support the development, implementation, and maintenance of the Quality Management System, including controlled procedures and processes, to maintain ongoing compliance with FDA, ISO 13485, and applicable regulatory requirements.
• Support regulatory compliance activities by maintaining required documentation, ensuring inspection readiness, and collaborating with Regulatory Affairs on required submissions and records.
• Assist in the planning, execution, and follow‑up of internal and external quality audits and inspections, including documentation review and timely remediation of audit findings.
• Support change control, risk management, and CAPA processes to ensure changes are assessed, approved, implemented, and documented in accordance with QMS requirements.
• Contribute to quality systems training activities to ensure personnel understanding of GMP, QMS procedures, and regulatory expectations.
• Demonstrate strong cross‑functional communication and accountability to support effective quality system implementation and sustain regulatory compliance.
• Consistently comply with EHS, GMP, and regulatory requirements, proactively supporting Baxter’s zero‑harm culture and responsibility for product quality and patient safety.

• Bachelor’s degree required.
• 0‑2 years of experience in quality assurance, manufacturing, or documentation.
• Experience with quality management systems, including implementation and maintenance.
• Strong knowledge of quality management systems such as ISO 13485 and FDA QSR and regulatory requirements.
• Strong communication and interpersonal skills, including experience working with cross‑functional teams.
• Strong analytical and problem‑solving skills, including experience identifying and resolving quality issues.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software.

• Experience in a medical device manufacturing environment.
• Familiarity with quality control tools and methodologies such as Six Sigma and Lean.
• Quality systems certification, such as…