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2 дня назад

Complaint Analyst (Medical Devices)

70 000 - 90 000$
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Complaint Analyst (Medical Devices): Managing the complaint lifecycle, investigating returned medical devices, and analyzing quality data with an accent on QMS tracking, failure-mode analysis, and FDA compliance. Focus on identifying root causes, detecting product-performance trends, preparing leadership reports, and closing cases accurately within regulatory deadlines.

Location: Onsite in San Mateo, California, 5 days a week

Salary: $70,000–$90,000 per year

Company

hirify.global develops non-invasive prescription therapies for chronic diseases, including neurological and cardiac conditions.

What you will do

  • Review inbound feedback, determine whether it qualifies as a formal complaint, and log cases accurately in Arena.
  • Process, handle, and physically inspect returned devices weighing up to 20 pounds to identify failure modes and root causes.
  • Track return rates, complaint metrics, and product-performance trends to identify improvement opportunities.
  • Prepare technical findings, trend analyses, and metric summaries for leadership review.
  • Apply QMS principles, internal SOPs, and FDA regulations throughout the complaint lifecycle.
  • Maintain thorough documentation and close complaint files accurately, compliantly, and on time.

Requirements

  • Associate or bachelor’s degree in engineering or a technical discipline.
  • Understanding of SQL and Python for database queries, sparse-record aggregation, and statistical analysis.
  • Strong written and verbal communication, analytical reasoning, attention to detail, and prioritization skills.
  • Ability to meet strict regulatory deadlines and maintain rigorous documentation standards.
  • Ability to lift, move, and handle package returns and testing objects weighing up to 20 pounds.
  • Must be authorized to work full-time in the United States or eligible for a sponsorship path supported by hirify.global.

Nice to have

  • Experience with QMS concepts and quality assurance in a medical device manufacturing environment.

Culture & Benefits

  • Access to tools, training, and mentoring to support professional development.
  • Work in a mission-driven medical technology environment focused on reducing the burden of chronic disease.
  • Commitment to diversity and an inclusive, non-discriminatory selection process.

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