2 дня назад
Complaint Analyst (Medical Devices)
70 000 - 90 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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 .
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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