Senior Design Assurance Engineer at Juul Labs | Torre
Senior Design Assurance Engineer
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Juul Labs

Senior Design Assurance Engineer

Juul Labs
Posted by
Mariajosé Gómez
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Full-time

Legal agreement: Employment

Compensation
USD102k - 122k/year
Non-negotiable
location_on
Hybrid (United States)
Posted almost 6 years ago

Responsibilities

• Independently support new product development and design changes ensuring product quality, reliability, speed to market, reduction of risk to users, and regulatory compliance • Reviews and approves Verification and Validation methods including performance, biocompatibility, and manufacturing processes to ensure requirements are met • Assists in the determination of sample size, confidence levels, and associated statistics pertaining to Verification and Validation activities • Responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to customers or regulatory compliance • Assist the Design Assurance function to build a comprehensive Design Assurance system compliant to FDA requirements, by reviewing Design Control procedures and policies, and assisting in document writing • Provides assistance and mentorship to JUUL Engineering to implement an improved and robust Design Control system • Reviews product change notices and change documentation to ensure thorough review of quality documents submitted for technical changes, design changes or manufacturing changes in order to ensure all regulatory requirements related to these changes are completely followed and conform to the Design Control regulations • Application of Reliability requirements, Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, ICH Q9, IEC 60601 and ISO 14971 Risk Management
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