Senior QC Engineer

2560 Orchard Parkway
San Jose , CA 95131
United States

Job Title:

Senior QC Engineer

Reports to:

Associate Director, Quality Control
FLSA Class:
Exempt

Learn more about our company and how we support you:
Takara Bio USA (TBUSA) empowers life science discovery. We bring innovation and inspiration to every scientist - promoting discoveries that improve health and the environment. We hold values that all employees and prospective candidates should demonstrate:
Innovation, Teamwork, Integrity, Respect, Growth, Diversity and Quality. We value helping employees develop their skills and you will be part of this journey!

At Takara Bio, we know that every experimental decision has an impact. Choices matter, from design to data analysis. We create best-in-class products that get the job done. In your hands, what do those research reagents and kits create? Something powerful: knowledge, understanding, and—often—hope! Together we can improve the human condition through biotechnology…and That's Good Science!

How this role drives the company forward:
The Senior QC Engineer is responsible for conducting quality control tests on reagents and instruments in compliance with all necessary regulations and ISO 13485 standards. This position requires the ability to work independently on established assignments, following documented procedures with precision and accuracy, and determines test processes on new assignments. The Senior QC Engineer works with R&D to help establish new product criteria and test processes.

This role exercises good judgement when resolving issues of diverse scope, in selecting techniques for process improvement, or obtaining solutions for complex problems. This role communicates effectively to management and other departments when performing troubleshooting experiments or other quality related tasks and presents data in cross-functional group meetings, as well as customer calls.

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

In this role, you will be responsible for ensuring the overall quality control tests on a diverse array of biotechnology reagent kits and instruments. Your primary objective is to confirm that the final products are safe, reliable, and meet specified expectations. You will work on maintaining and updating standard operating procedures (SOPs) and relevant documentation for each product.

You will participate in troubleshooting experiments, analyze the resulting data, and present your findings to relevant team members within the company. You will collaborate with the Research and Development team to develop quality control related processes for new product. Furthermore, you will implement process improvement projects and engage in quality improvement activities. You will participate in both external and internal audits as required.

You will also provide training for other team members.

• 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…