The QC Engineer is an on-site, lab-based role located in San Jose, CA.

• Responsible for testing assigned products.
• Responsible for review of vendor supplied test results to ensure compliance with product specifications.
• Responsible for the implementation of quality procedures to optimize testing processes.
• Maintains records and follows good manufacturing practices and standard operating procedures.
• Writes and updates QC work instructions, SOPs and other technical documents as needed.
• Make decisions on moderate to complex issues and independent decisions on simple issues.
• Interacts with various groups, shares information/troubleshooting results, and participate in team activities.
• Participates in quality and process improvement projects. Specific tasks are dependent on assigned projects.
• Flexibility in supporting changing priorities with short notice.
• Assists with the calibration and maintenance of laboratory equipment.
• Maintains stocked supply of communal reagents and materials.
• May assist in the manufacturing processes as needed.
• Serves as a QC resource to other departments within the organization.
• Perform other miscellaneous lab maintenance activities.
• Supports the transfer of new products and technologies from R&D to the QC department.
• May train Associate Quality Control Engineer level.
• Manages and drives resolution of quality issues with other departments within organization.
• This position does not have supervisory responsibilities.

• Bachelor’s degree in a scientific discipline and a minimum 5 years of hands-on experience in a life science or medical device /IVD industry in a laboratory quality role; or 3 years and a Master’s degree; or a Ph.D. without experience.
• Understands the basics of modern biochemistry and a firm background in quantitative methods is required.

• Prior experience in instrument automation.
• Experience in BSL2 lab facility.
• Effective analytical and problem-solving skills, including attention to detail.
• Strong verbal and written communication skills.
• Ability to work independently on routine tasks, establish priorities to meet deadlines and prepare written information in a clear and concise fashion.
• Strong planning, organizational and interpersonal skills.
• Working knowledge and experience in the use of computer and computer programs such as Microsoft Office, FileMaker, Adobe Acrobat, ERP system.