Product Complaint Specialist I

Responsibilities

• Document and manage customer complaints and feedback in accordance with ISO 9001, ISO 13485, and regulatory requirements
• Review complaint records for completeness and accuracy and collaborate with internal teams to collect required information
• Assist in reviewing complaint investigations, including root cause analysis, for adequacy
• Collaborate with cross-functional teams to drive timely completion of investigations and related activities
• Assess the need for Corrective and Preventive Actions (CAPA) resulting from complaints
• Participate in Material Review Board meetings to review and approve product dispositions
• Generate, analyze, and report quality metrics to assess QMS performance
• Assist with quality-related documentation and support internal and external audits

Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Life Sciences, or Engineering
• Proficiency in Microsoft Office Suite
• Strong analytical problem-solving skills and understanding of root cause analysis methodologies
• High attention to detail and ability to manage multiple priorities in a fast-paced environment
• Excellent verbal and written communication skills

Preferred Qualifications

• 1-2 years of experience in biotechnology, medical devices, in vitro diagnostics, or pharmaceuticals
• Working knowledge of ISO 9001 or ISO 13485
• Experience developing metrics, analyzing data, and generating reports
• Experience supporting recalls, corrections, or field actions
• ASQ Certification (e.g., CQE, CRE, CQA)

Benefits

• Medical, dental, and vision coverage with prescription benefits
• 401(k) plan with company matching
• Paid vacation, sick leave, holidays, and parental leave
• Company-paid short-term and long-term disability insurance
• Employee assistance program and various voluntary perks including fitness club contributions

About the Company

Meso Scale Diagnostics (MSD) is a leader in providing advanced technologies for the development of highly sensitive assays used in life science research and clinical diagnostics.