Product Assurance Complaint Analyst (Medtech)

Location: Plymouth, MN, US; hybrid

Salary: USD 75,000–85,000 annually

Company

Commercial-stage medtech company developing the Edison® System, a non-invasive histotripsy therapy platform for liver tumors and future applications across multiple medical specialties.

What you will do

• Receive, acknowledge, triage, document, track, and close product feedback and complaints in the complaint management system.
• Assess potential patient safety impact and escalate potentially reportable events to the Complaint Manager and Regulatory Affairs.
• Coordinate complaint investigations with Product Assurance, Regulatory Affairs, Product Development, Manufacturing, Clinical, and Service teams.
• Document root-cause analyses, investigation findings, follow-up actions, and device returns.
• Compile complaint metrics, apply FDA/IMDRF event coding, identify adverse trends, and support post-market surveillance, CAPA, and management reviews.
• Maintain traceable, retrievable, inspection-ready records and support audits and complaint-handling procedure updates.

Requirements

• 2+ years of quality experience in the medical device industry or another regulated industry.
• Bachelor’s degree in science, engineering, or a related field preferred.
• Ability to understand technical and clinical information related to medical device performance.
• Ability to compile, analyze, and present data, including Excel-based trending.
• Strong organizational and follow-up skills, with attention to detail and documentation accuracy.
• Experience with complaint handling or other post-market quality processes.
• Working knowledge of FDA 21 CFR Part 820/QMSR, 21 CFR Part 803, ISO 13485:2016, and ISO 14971:2019.

Nice to have

• Experience with an electronic quality management system (eQMS).
• Familiarity with EU MDR (2017/745) vigilance requirements.

Culture & Benefits

• Hybrid work arrangement in Plymouth, Minnesota.
• Work in a commercial-stage medtech environment connecting scientific development with clinical application.
• Equal opportunity workplace committed to diversity and nondiscrimination.
• Visa sponsorship is not available; U.S. work authorization is required.