Job Description
Job Description
A manufacturer of medical devices and laboratory technologies has two open positions for a Complaints Specialist on a Full Time, Direct Hire basis. The Complaints 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 Complaints 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:
o Supporting CAPA initiation, investigation, and closure activities.
o 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 Laboratory, Technical Support, QA/RA, or Compliance in a biotechnology, medical device or related field.
- Exposure to or experience with Cell Culture or Cytogenetics (education or industry) is required.
- 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.