Takara Bio USA, Inc. · 5 hours ago
Senior QC Engineer
San Jose, CA
Full-time
Onsite
Senior Level
$130K/yr - $140K/yr
6+ years expTakara Bio USA, Inc. empowers life science discovery and innovation. The Senior QC Engineer is responsible for conducting quality control tests on reagents and instruments, ensuring compliance with regulations and ISO 13485 standards while collaborating with R&D to establish new product criteria and test processes.
BiotechnologyCustomer ServiceDeliveryShipping
Responsibilities
Responsible for testing assigned products
Chairs meetings in coordinating cross -functional quality improvement projects related to product testing, acceptance QC criteria, vendor’s validation, troubleshooting. Specific tasks and actions are dependent upon the product line assigned to the position
Responsible for review of vendor supplied test results to ensure compliance with product specifications
Facilitates resolution of quality issues by interacting with key personnel or vendor for OEM products
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
Makes independent decisions on complex issues in collaboration with other relevant team members and in alignment with company policies
Interacts with various groups, shares information/troubleshooting results, and participate in team activities
Flexibility in supporting changing priorities with short notice
Assists in maintaining inventory accuracy through efficient management of product work orders and cycle count activities
Maintains stocked supply of communal reagents and materials
Serves as a QC resource to other departments within the organization
Lead QC group on miscellaneous lab maintenance activities
Lead QC teams to Support the transfer of new products and technologies from R&D to the QC department
Train Associate Quality Control Engineer or Quality Control Engineer as needed
Manages and drives resolution of quality issues with other departments within organization with minimum supervision
This position does not have supervisory responsibilities
Qualification
Required
Bachelor's degree in a scientific discipline and a minimum 8 years of hands-on experience in a life science or medical device /IVD industry in a laboratory quality role; or 6 years and a Master's degree; or 3 years and a Ph.D
Practical Experience of modern biochemistry and a firm background in quantitative methods is required
Experience in BSL2 lab facility is required
Effective analytical and problem-solving skills, including attention to detail
Strong verbal and written communication skills
Ability to work independently on assigned tasks, establish priorities to meet deadlines and prepare written information in a clear and concise fashion
Strong planning, organizational, collaboration and communication skills with colleagues and external collaborators
Preferred
Proficient in the use of computer and computer programs, such as: Microsoft Office, FileMaker, Adobe Acrobat, Arena, ERP system, Jira
Prior experience in instrument automation
Company
Takara Bio USA, Inc.
Takara Bio USA, Inc.
201-500 employees
H1B Sponsorship
Takara Bio USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (7)
2022 (6)
Funding
Current Stage
Growth StageLeadership Team
Carol Lou
President & CEO
Andrew Farmer
CSO / Head of Research and Development
Recent News
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