Senior Quality Engineer - Design Assurance
Cepheid(4 days ago)
About this role
The Senior Engineer, Quality Assurance at Mammotome supports design control and risk management activities to ensure compliance and aid in bringing new medical devices to market. The role involves cross-functional collaboration, maintaining quality systems, and supporting regulatory audits. It is based in Cincinnati, Ohio, and involves working onsite.
Required Skills
- ISO 14971
- Design Control
- Risk Management
- FDA Regulations
- ISO 13485
- Process Validation
- Quality Systems
- Medical Device
- Regulatory Compliance
- Risk Analysis
Qualifications
- B.Sc. in Engineering
About Cepheid
cepheid.comCepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.
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