Emplois actuels liés à Quality Assurance Specialist - Marseille, Provence-Alpes-Côte d'Azur - Beckman Coulter Life Sciences
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il y a 4 semaines
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il y a 4 semaines
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Quality Assurance Specialist
Il y a 2 mois
Beckman Coulter Life Sciences is committed to empowering those seeking answers to life's most important scientific and healthcare questions. We are currently seeking a Quality Assurance Engineer who will play a crucial role in ensuring compliance of the documentation and process related to the design control process.
Key Responsibilities:- Collaborate with development teams to organize projects in compliance with international standards and regulations applicable to in vitro diagnostic medical devices.
- Participate in the implementation and monitoring of Quality indicators associated with your activity.
- Coordinate reviews with stakeholders (Engineering, R&D, Manufacturing, Quality Control, Registration Team).
- Develop and propose solutions to improve processes and product quality.
- Master's degree in science, medical, or equivalent or PhD with at least 5 years of experience on design control or similar position.
- Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR), ISO 13485 and IVDR EU 2017/746, ISO 9001.
- In Vitro Diagnostics (IVD) experience including medical device development.
We value diversity and inclusion at Beckman Coulter Life Sciences. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.
