4 часа назад
Senior Post-Market Quality Engineer (Medical Devices)
110 000 - 132 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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