Risk Management Expert in Quality Assurance
Há 1 mês
Ambit is looking for a seasoned Risk Management Expert to join our team.
As a Risk Management Expert in Quality Assurance, you will play a crucial role in ensuring the safety and reliability of our products throughout their lifecycle.
The job involves:
- Coordinating cross-functional teams to execute product safety risk management activities.
- Creating and maintaining product-specific safety risk files.
- Developing product-specific risk policies aligned with the risk management framework.
- Assessing quality information and customer feedback for impact on product risk and customer safety.
Requirements:
To succeed in this position, you should have:
- Bachelor's degree in physical science, engineering, or a related field, preferred.
- 2+ years of experience in a highly regulated industry, preferably within the Medical Device, pharmaceutical, or life sciences industry.
- Thorough working knowledge of relevant international ISO/IEC Standards (13485 , 14971 , 62304 , 62366 , 82304 ).
- Knowledge/Experience in regulations (MDSAP, MDD/IVDD, MDR/IVDR, 21 CFR - Part 820), and associated guidances preferred.
- Demonstrated ability to communicate, collaborate, and influence effectively with a variety of internal/external stakeholders.
What We Offer:
We offer a competitive salary package based on your profile, a permanent contract, learning and development opportunities, and a flexible schedule from Monday to Friday, 08:00-18:00 hours. You will be working remotely 100% of the time. English fluency is required.
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