Quality Complaints Specialist

The Quality Assurance (QA) Complaint Investigator is responsible for conducting end-to-end complaint investigations for manufacturing and packaging issues related to prefilled devices, drug/device combination products, and parenteral products. This role focuses on evaluating incoming complaints, coordinating cross-functional investigations, and synthesizing findings into clear, compliant investigation reports in a regulated environment. This position plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement by identifying trends, supporting root cause analysis, and providing actionable recommendations. Key Responsibilities Complaint Review & Triage Review and triage incoming complaints daily (5–6 per day; ~20–30 per week) Full investigation vs. documentation review Monitor and document complaint intake and triage decisions Conduct thorough complaint investigations (~75% require full investigation) Review product and batch history, including prior complaints and related deviations Collaborate with subject matter experts (SMEs) to support: Batch record reviews Technical evaluations Initiate and support RCIs, trend investigations, and technical tasks as needed Data Analysis & Reporting Compile investigation findings into formal, compliant reports Develop clear conclusion statements and recommend next steps (e.g., root cause analysis, CAPAs) Perform quarterly trend analysis on product and process performance Prepare and deliver monthly, quarterly, and ad hoc metrics and reports Present complaint data to site leadership and cross-functional teams Cross-Functional Collaboration Partner with SMEs, quality, manufacturing, and engineering teams to support investigations Provide customer service and investigation support to internal and external stakeholders Maintain accountability for all assigned investigations and deliverables Support process improvements and productivity initiatives within the complaints program Identify recurring issues and contribute to quality system enhancements Basic Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related field Minimum of 3 years of experience in a regulated industry (pharma, biotech, or medical device) Experience with complaint investigations and quality systems Knowledge of regulatory requirements (cGMP, 21 CFR Part 820, ISO 13485) Strong analytical, problem-solving, and organizational skills Excellent written and verbal communication skills Proficiency with Microsoft Office; experience with Veeva or other QMS systems preferred Basic understanding of statistics and data analysis #J-18808-Ljbffr Insight Global