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Senior Design Quality Assurance Engineer
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$150
- Lead risk evaluation for pre-market and post-market issues for product safety, including completion of the risk documentation and the risk management file
- Collaborate and guide with cross-functional team members and stakeholders to ensure implementation of Design Controls and Quality Systems
- Participate in the CAPA process and work with CAPA owners to address and close CAPAs in a timely manner
- BS or MS degree in Software Engineering, Biomedical Engineering, Electical Engineering, Computer Science, Regulatory Affairs or another scientific discipline
- Ability to lead and manage various Regulatory activities and meetings including CAPA, risk analysis, documentation and audit meetings
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