Sr Quality Assurance Engineer
Insulet(3 months ago)
About this role
The Senior Quality Engineer ensures Insulet products conform to the company Quality System, FDA Quality System Regulation, ISO 13485 and ISO 14971 standards. The role serves as a Quality representative across cross-functional teams to support new product introduction, risk management, and product commercialization. The engineer communicates quality initiatives and drives resolution of quality issues to support departmental and corporate quality goals.
Required Skills
- Risk Management
- Design Control
- Regulatory Compliance
- DHF Management
- Process Development
- Verification
- Validation
- Statistical Methods
- Technical Writing
- Communication
Qualifications
- BS in Engineering
- MS in Engineering (Preferred)
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