Position

The Analyst I, Complaint Investigation specialist is responsible for investigating product complaints, conducting laboratory testing, analyzing technical data, and documenting investigation results to support product quality and regulatory compliance. This role partners closely with manufacturing sites, suppliers, Product Legal Manufacturer (PLM) teams, Quality Engineers, and other cross-functional stakeholders to identify root causes, resolve product quality issues, and ensure compliance with FDA, ISO, GMP, and GLP requirements.

The position requires strong attention to detail, effective problem-solving skills, and the ability to work collaboratively in both laboratory and office environments. The Complaint Investigation Specialist I is responsible for conducting and documenting comprehensive complaint investigations, including product testing, and effectively planning, organizing, and tracking all activities associated with complaint records. A strong commitment to quality and accuracy is essential to ensure the integrity, completeness, and regulatory compliance of complaint investigations.

Success in this role is driven by active in-office collaboration, enabling real-time engagement with experienced investigators, laboratory teams, and cross-functional partners to accelerate learning, enhance problem-solving capabilities, and support timely investigation outcomes. This onsite presence promotes knowledge sharing, team alignment, and contributions to both individual and departmental objectives.

Essential Responsibilities

• Conduct complaint investigations for UCC products, including OEM-manufactured products, ensuring timely, thorough, and compliant resolution.
• Perform laboratory testing and experiments in accordance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable quality system requirements.
• Analyze complaint data, test results, and technical information to identify root causes and support evidence-based conclusions.
• Document investigation activities, test results, and findings accurately and completely in accordance with FDA, ISO, and internal quality system requirements.
• Manage assigned complaint investigation records and ensure timely progression and closure of investigations.
• Provide technical support for product quality issues, including complaint evaluation, investigation, and escalation of reportable events in accordance with regulatory requirements.
• Collaborate with manufacturing facilities, suppliers, Product Legal Manufacturer (PLM) teams, and Quality partners to support investigations and product quality improvements.
• Prepare, operate, maintain, and troubleshoot laboratory equipment and testing instruments in a safe and compliant manner.
• Communicate investigation findings, conclusions, and recommendations effectively to cross-functional teams and management.
• Work safely within a biohazard laboratory environment while adhering to all safety policies and procedures.
• Support continuous improvement initiatives and contribute to departmental objectives and quality system enhancements.
• Maintain regular onsite presence to support laboratory activities, hands-on training, cross-functional collaboration, knowledge sharing, and timely issue resolution.

Minimum Qualifications

• Bachelor's degree in a scientific, life sciences, engineering, or related technical discipline required.
• 1-3 years of experience in a regulated industry (medical device, pharmaceutical, biotechnology, or similar); relevant co-op or internship experience will be considered.
• Experience working with technical documentation, laboratory testing, data analysis, and quality system processes.
• Working knowledge of FDA, ISO 13485, GMP, GLP, and complaint-handling requirements.
• Proficiency in Microsoft Excel, including functions such as PivotTables, VLOOKUP/XLOOKUP, and basic data analysis tools.
• Strong written and verbal communication skills.
• Demonstrated ability to manage multiple priorities while maintaining a high degree of accuracy and attention to detail.
• Applicants must be authorized to work for any employer in the United States. The company is not able to sponsor or take over sponsorship of an employment visa at this time.

Preferred Qualifications

• Experience conducting complaint investigations within a medical device or pharmaceutical environment.
• Laboratory testing experience, including sample preparation, test execution, and equipment operation.
• Experience with root cause analysis methodologies and problem-solving tools (e.g., 5 Whys, Fishbone, CAPA, FMEA).
• Knowledge of medical device manufacturing processes and product quality systems.
• ASQ certification (CQE, CQA, CQM, or equivalent) preferred.

Knowledge, Skills, and Abilities

• Working knowledge of medical device regulations and standards, including FDA, ISO 13485, Quality System Regulations (QSR), GMP, GLP, and applicable industry guidelines.
• Strong laboratory and analytical skills, including hands-on experience with testing methods, instrumentation, and equipment troubleshooting.
• Understanding of manufacturing processes and their impact on product quality and complaint investigation outcomes.
• Ability to collect, interpret, and analyze technical data and draw sound, evidence-based conclusions.
• Knowledge of engineering and scientific principles related to product evaluation, failure analysis, and root cause investigations.
• Effective verbal and written communication skills, including the ability to present technical information to cross-functional audiences.
• Strong technical writing skills with the ability to prepare clear, concise, and well-organized investigation reports and documentation.
• Excellent organizational and time management skills, with the ability to prioritize competing demands and meet deadlines.
• Ability to interpret and apply corporate, departmental, and regulatory requirements within a regulated environment.
• Self-motivated and capable of working independently while also contributing effectively within a team environment.
• Demonstrated critical thinking and sound judgment when evaluating complaints, investigation results, and potential regulatory impact.
• Ability to recognize and appropriately escalate product quality concerns that may have regulatory, business, or patient safety implications.

Work Environment

• Primarily office and laboratory-based environment.
• Requires routine work within a laboratory setting, including potential exposure to biohazard materials while following established safety procedures.
• Requires frequent use of laboratory equipment, testing instruments, and computer systems.
• Regular onsite presence is required to support laboratory testing, investigator development, cross-functional collaboration, and timely complaint resolution.