Complaints Analyst - Medical device

Job Title: Complaints Analyst - Medical device

Location: Minnesota

Pay Rate: $40 - $45/hr (DOE)

Duration: 12 Months

Position Overview:

Seeking a Complaints Technician to support post-market quality activities within a medical device environment. This role is focused on hands-on technical investigation of returned capital equipment, including computer-based systems, associated with customer complaints.

The Complaints Technician will perform failure analysis, document investigation findings, review manufacturing data for potential trends, and support corrective and preventive actions. This position is well suited for a technically experienced professional who enjoys hands-on troubleshooting and quality investigation work.

Key Responsibilities:

• Conduct independent investigations and failure analyses of returned capital equipment associated with customer complaints
• Evaluate equipment, components, and available technical information to identify potential failure modes and contributing factors
• Use applicable testing tools and procedures to support root cause investigations
• Document investigation activities, findings, conclusions, and supporting evidence in accordance with quality procedures
• Review manufacturing and quality data to identify trends, recurring issues, and potential product or process concerns
• Support NCEP investigations and resolution activities
• Support CAPA investigations and implementation of corrective and preventive actions
• Collaborate with Quality, Engineering, Manufacturing, and other cross-functional teams during complaint investigations
• Support laboratory operations and contribute to laboratory process improvements
• Follow applicable SOPs, work instructions, quality procedures, and safety requirements
• Maintain accurate and complete investigation records and supporting documentation
• Communicate technical findings and investigation status to appropriate stakeholders

Preferred Qualifications:

• High school diploma or equivalent plus approximately two years of relevant technical, manufacturing, quality, laboratory, or troubleshooting experience; equivalent combinations of education and experience may be considered where permitted by applicable requirements
• Experience in medical device manufacturing, post-market quality, complaints, quality investigations, or a regulated manufacturing environment is preferred
• Hands-on troubleshooting or failure-analysis experience is preferred
• Experience with CAPA, NCEP, nonconformance, or quality investigation processes is preferred