San Jose, CA US
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.