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Senior Quality Engineer (Electrical & Software Engineering)

EBR Systems, Inc. · Sunnyvale, California, US

Description Position Summary The Senior Quality Engineer will incorporate cross-functional project teams and contribute to product specification development...

Job description

Description Position Summary: The Senior Quality Engineer will incorporate cross-functional project teams and contribute to product specification development and quality planning activities. Responsibilities include authoring and managing documentation for design verification and validation, software and process validations, human factors, and risk analysis. Lead the analysis of complaint and ensure compliance with quality management systems and regulatory requirements. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial. Essential duties and responsibilities include, but are not limited to, the following: Job Responsibilities - Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records. Support regulatory audits of Product Development function and outputs. - Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix. - Responsible for quality engineering review of Doc...