An early stage well-funded venture company is looking to hire excellent members to its team. The company is comprised of industry veterans and respected academics located in Silicon Valley and is focused on developing novel diagnostic tests for infectious diseases. This position reports to the Director of Quality and Regulatory.
Scope of Position
The Staff Quality Engineer is an enthusiastic, self-motivated individual with great communication skills who can support the development, implementation, and management of the Quality Management Systems to ISO 13485 and FDA QSR. The Staff Quality Engineer will demonstrate a high level of individual responsibility and accountability.
- Create, update, review and develop Quality Management System standard operating procedures and supporting work instructions per ISO 13485 and FDA QSR
- Train personnel in requirements of Quality systems, tools, and techniques based on ISO 13485 and FDA QSR
- Perform root cause data analysis using statistical techniques
- Write and perform qualification, verification/validation protocols
- Create and maintain quality metrics as they relate to Quality systems and Operations
- Develop and maintain Internal Audit program and schedule
- Develop and maintain Supplier Quality program including supplier audit
- Review and approve Material Review Board and Change Control Board activities
- Support Product Life Cycle Development and New Product Development activities as Quality representative