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4 часа назад

Senior Post-Market Quality Engineer (Medical Devices)

110 000 - 132 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Post-Market Quality Engineer (Medical Devices): Ensuring the safety, effectiveness, and regulatory compliance of marketed medical devices throughout their lifecycle with an accent on post-market data analysis, complaint handling, surveillance, CAPA, and risk management. Focus on identifying product trends, investigating issues, and implementing quality improvements in collaboration with Regulatory, Clinical, Operations, and R&D.

Location: Onsite in Burnsville, Minnesota, United States

Annual base salary: $110,000–$132,000

Company

Medical-device company developing and supporting marketed products throughout their lifecycle.

What you will do

  • Analyze and trend post-market data to identify product and safety signals.
  • Handle complaints and investigate product issues.
  • Develop and maintain post-market surveillance plans and reports.
  • Manage corrective and preventive action activities and risk management.
  • Collaborate with Regulatory, Clinical, Operations, and R&D teams to implement quality improvements.
  • Support the safety, effectiveness, performance, and regulatory compliance of marketed medical devices.

Requirements

  • Availability to work onsite at the Burnsville, Minnesota location is required.
  • Senior-level experience in post-market quality engineering for medical devices.
  • Experience with post-market data analysis and trending.
  • Knowledge of complaint handling, post-market surveillance, CAPA, and risk management.
  • Ability to collaborate cross-functionally with Regulatory, Clinical, Operations, and R&D.

Culture & Benefits

  • Cross-functional collaboration across quality, regulatory, clinical, operations, and R&D functions.
  • Medical, dental, and vision benefits.
  • Health Savings Account and Health Care & Dependent Care Flexible Spending Accounts.
  • Disability and life insurance benefits.
  • Retirement benefits.

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