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Complaint Specialist Intern

Remote, USA

Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.

The Complaint Specialist Intern will support the Quality team in processing product complaints and post-market surveillance activities. This role offers hands-on experience in medical device quality systems, regulatory compliance, and cross-functional collaboration. The intern will gain exposure to complaint handling processes in alignment with global standards (FDA 21 CFR Part 820 and ISO 13485). 

Roles & Responsibilities | What you'll do:

1. Complaint Review & Verification

  • Review complaint intake information for accuracy, completeness, and consistency.
  • Confirm that product, event, and customer details are properly documented.
  • Ensure complaint records meet regulatory and internal quality requirements.

2. Investigation Support

  • Support complaint investigations by gathering data, reviewing product history, and compiling reports.
  • Collaborate with cross-functional teams (Customer Care and Sustaining) to collect investigation inputs

3. Regulatory & Compliance Support

  • Help assess complaint records for potential reportability under global regulations.
  • Support preparation for complaint review summaries for internal review.

4. Data Analysis & Reporting

  • Assist in trending complaint data and preparing dashboards or presentations.
  • Support the Quality team in identifying recurring issues or signals.

5. Audit & Continuous Improvement

  • Help organize complaint files for internal/external audits.
  • Participate in process improvement initiatives to streamline complaint handling.

 

Qualifications:

  • Current student or recent graduate in Bioengineering, Biomedical Engineering, Life Sciences, Engineering, or related field.
  • Interest in medical devices, quality systems, and regulatory compliance.
  • Strong attention to detail and organizational skills.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a team.

Learning Outcomes:

  • Hands-on experience with complaint handling and post-market surveillance processes.
  • Exposure to regulatory standards (FDA, ISO).
  • Development of analytical and cross-functional collaboration skills.
  • Practical knowledge of quality system operations in the medical device industry.

 

This is part-time internship working 20 hours or less per week for a term of up to 3 months. The rate for this role is $25.00/hour.

Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status. 

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