Product Assurance Complaint Analyst

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Plymouth, MN (Hybrid)

Position Summary (Why this role matters):

The Product Assurance Complaint Analyst supports the complaint handling process by ensuring that complaints are received, documented, evaluated, and tracked in compliance with the FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), ISO 13485, other applicable regulations, and internal procedures. This role monitors all sources of product feedback, prepares complete and accurate complaint records, coordinates information gathering with cross-functional teams, and supports reportability assessments, investigations, and timely closure. The Analyst also compiles complaint data to support trending and post-market surveillance and helps keep complaint records inspection ready.

Key Responsibilities (What you’ll do):

• Complaint Intake & Documentation:
  • Receive, acknowledge, and log feedback from all sources (e.g., customers, clinical and field personnel, service, distributors, and post-market surveillance) in the complaint management system within the timelines defined in company procedures.
  • Create complete and accurate complaint records that include the content required by 21 CFR Part 820 (QMSR), ISO 13485, and company procedures.
  • Perform initial triage to determine whether feedback meets the definition of a complaint, assess potential patient safety impact (e.g., death, serious injury, or malfunction), and escalate potentially reportable events immediately to the Complaint Manager and Regulatory Affairs as required.
  • Follow up with complainants to obtain missing information, arrange return of devices when applicable, and communicate responses as directed.
• Complaint Evaluation & Investigation Support:
  • Collaborate with relevant internal teams (e.g., Product Assurance, Regulatory Affairs, Product Development, Manufacturing, Clinical, and Service) to investigate complaints.
  • Ensure root cause analysis is documented to determine whether the complaint is related to device design, manufacturing processes, labeling, or external factors.
  • Ensure investigation findings are documented, and all necessary follow-up actions are taken.
• Regulatory Compliance:
  • Ensure complaints are handled in compliance with FDA regulations, ISO 13485, and other applicable standards.
  • Gather and document the event information Regulatory Affairs needs to determine reportability (e.g., Medical Device Reports (MDRs) under 21 CFR Part 803 and international vigilance reports), and track reports to on-time submission.
• Trending & Reporting:
  • Compile and maintain complaint data and metrics to support trending, post-market surveillance, and management review inputs.
  • Apply standardized complaint and event coding (e.g., FDA/IMDRF adverse event codes) to support consistent trending and reporting.
  • Identify potential adverse trends or signals and escalate to the Complaint Manager for evaluation, including consideration of CAPA, and provide complaint data and records to support CAPA activities.
• Documentation & Record Keeping:
  • Maintain accurate, organized, and legible complaint records that are traceable and retrievable in accordance with company record retention requirements.
  • Monitor open complaints, follow up on overdue actions, and ensure timely closure and archiving within procedural timelines.
  • Present complaint status and metrics at complaint review board, CAPA review, or management review meetings as requested.
• Support internal and external audit activities as needed.
• Support the development and maintenance of complaint handling procedures, work instructions, and forms.
• Maintain a safe and clean work environment.
• Other duties as assigned by the Product Assurance Complaint Manager or Director of Product Assurance.

Qualifications and Skills:

• Bachelor's degree in science, engineering, or related field preferred
• 2+ years of quality experience in the medical device industry or another regulated industry
• Ability to understand technical and clinical information related to medical device performance
• Ability to compile, analyze, and present data (e.g., Excel) to support trending
• Strong organizational and follow-up skills, as well as attention to detail and accuracy in documentation
• Experience with complaint handling or other post-market quality processes; experience with an electronic quality management system (eQMS) is preferred
• Working knowledge of FDA 21 CFR Part 820 (QMSR), 21 CFR Part 803, ISO 13485:2016, and ISO 14971:2019; familiarity with EU MDR (2017/745) vigilance requirements is a plus

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.