Complaint Specialist

Job Description

Job Description

A manufacturer of medical devices and laboratory technologies has two open positions for a Technical Investigation Specialist on a Full Time, Direct Hire basis. The Technical Investigation Specialist will ensure appropriate product compliance is in line with SOPs and RA/QA requirements, which includes tasks related to Complaints and CAPA. Participate in customer complaint and inquiry processes, including but not limited to, complaint intake, documentation and lead of assigned investigations, customer follow-up and management, and tracking, trending and reporting of Technical Investigations Program management and activities. Investigate customer inquiries, complaint and/or CAPA investigations, as assigned, with support from cross-functional teams, and communicate directly with customers.

The Technical Investigation Specialist will:

• Support investigations for customer inquiries, complaints, and CAPAs as assigned.
• Assist in ensuring timely resolution and documentation of customer inquiries, including troubleshooting and coordination with internal teams such as Customer Support, Sales, FAS, and R&D.
• Contribute to maintaining high levels of customer satisfaction through effective communication and follow-up.
• Support continuous improvement initiatives for productivity, customer satisfaction, and customer engagement metrics.
• Participate in implementation of solutions to product-related issues with guidance from senior team members
• Perform product compliance activities, including but not limited to: Supporting CAPA initiation, investigation, and closure activities & Complaint documentation intake, investigation support, and tracking/trending/reporting.
• Classify and help triage customer inquiries for appropriate resolution.
• Support timely closure of complaints.
• Follow established processes and procedures to ensure compliance with applicable standards.
• Perform other duties as assigned.

Requirements:

• Bachelor's degree (B.S. or B.A.) in a scientific discipline preferred. Equivalent combinations of education and experience will be considered.
• 1–3 years of experience in Technical Support, Customer Service, QA/RA, or Compliance in a medical device or related field.
• Experience in TrackWise or similar electronic systems.
• Basic knowledge of GMPs, ISO 13485, and applicable regulatory standards.
• Understanding of quality systems and documentation practices.
• Familiarity with root cause analysis principles (training acceptable).
• Experience with risk management concepts (FMEA exposure preferred).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong communication (written and verbal) skills.
• Ability to communicate effectively in spoken and written English is required to perform the essential functions of the position. Additional language skills are a plus.