2 дня назад
QA Specialist – Post Market (Medical Devices)
74 000 - 93 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Specialist – Post Market (Medical Devices): Managing post-market complaints, investigation reports, adverse event reporting, and complaint trends with an accent on medical device regulations, vigilance, and reporting timelines. Focus on evaluating reportability across USA, European, and Japan requirements, coordinating moderately complex investigations, and analyzing technical information for root cause assessment.
Location: Remote - US
Salary: $74,000–$93,000 per year
Company
is a digital healthcare company developing wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health.
What you will do
- Review and evaluate routine to moderately complex post-market complaints.
- Determine complaint reportability under USA, European, and Japan adverse event reporting requirements.
- Perform or coordinate complaint investigations and prepare investigation reports.
- Analyze technical information to support root cause assessments using established methods.
- Maintain complaint logs and trends, identify issues for escalation, and support process improvements.
- Collaborate cross-functionally on quality and regulatory activities.
Requirements
- Bachelor’s or associate degree in science, technology, or a medical field.
- At least 2 years of experience in quality assurance and/or complaint processing.
- Working knowledge of global medical device regulations related to complaint handling, vigilance, reporting timelines, and post-market surveillance.
- Strong written and verbal communication skills.
- Must be located in the United States for the remote role.
Culture & Benefits
- Work in a patient-first digital healthcare environment focused on cardiac health.
- Inclusive workforce that values diverse backgrounds, experiences, skills, and perspectives.
- Reasonable accommodations are available for qualified individuals with disabilities during the application process.
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