Complaint Specialist

This contract position supports post‑market quality and complaint investigation activities within a regulated environment. The role focuses on evaluating returned products associated with customer complaints, performing technical investigations, and documenting findings in accordance with established quality system and regulatory requirements. The scope may include complex systems or capital equipment, as well as other devices and components.

This role works cross‑functionally with teams such as Quality, Engineering, Manufacturing, Supplier Management, and Operations to support thorough analysis, risk assessment, and issue resolution. The ideal candidate can ramp up quickly, work independently, and contribute immediately in a fast‑paced setting.

• Conduct complaint investigations of returned products under supervision or established procedures
• Perform basic failure analysis using approved tools, methods, and test techniques
• Review device history records, manufacturing data, and complaint trends to support root cause analysis
• Complete investigation documentation accurately, including coding and conclusions aligned with test results
• Support quality system activities such as nonconforming events, corrective and preventive actions (CAPA), and investigations
• Partner with cross‑functional teams to support resolution of product and process issues
• Escalate potential quality or safety concerns following defined procedures
• Contribute to continuous improvement initiatives and process enhancements
• Provide support for lab operations, testing activities, and investigation workflows as needed

• High school diploma with a minimum of 2 years of relevant work experience, or an equivalent combination of education and experience
• Ability to follow established procedures and document work clearly and consistently
• Strong attention to detail and organizational skills

• Experience in a quality, manufacturing, or technical role within a regulated industry (medical device experience preferred)
• Exposure to complaint handling, post‑market surveillance, or product investigations
• Basic knowledge of Quality System Regulations (QSR), ISO 13485, or similar standards
• Familiarity with root cause analysis and problem‑solving methodologies
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Ability to collaborate effectively with cross‑functional teams
• Self‑motivated, with the ability to learn quickly in a contract environment