Quality Specialist, Complaints

Responsibilities

• Perform documented customer complaint investigations in accordance with FDA 21 CFR Part 820 and ISO 13485 requirements, including review of Device History Records (DHRs), product history, test data, and customer information.
• Apply structured root cause analysis methodologies (e.g., 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 (QMS), 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.

Requirements

• Bachelor's degree required. 0-2 years of experience in quality assurance, manufacturing or documentation.
• Experience with quality management systems, including experience in implementing and maintaining QMS.
• Strong knowledge of quality management systems (e.g., ISO 13485, FDA QSR) and regulatory requirements.
• Strong communication and interpersonal skills, including experience in working with cross-functional teams.
• Strong analytical and problem-solving skills, including experience in 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 (e.g., Six Sigma, Lean).
• Quality systems certification, such as CQIA or CQE.
• Physical & Work Environment Requirements
• Ability to stand and walk for extended periods, including up to a full workday, to support meetings, audits, inspections, and on‑site quality activities.
• Ability to sit for prolonged periods while reviewing documentation, performing data analysis, and participating in meetings.
• Capability to lift and carry materials, equipment, or documents weighing up to approximately 25 pounds as required for audits and inspections.
• Ability to bend, stoop, and reach as necessary to access equipment, documentation, and work areas.
• Work Environment & Conditions
• Primary work conducted in an office environment, with periodic presence in manufacturing and warehouse settings to support quality activities and inspections.
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Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. 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.

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