Senior QC Engineer

Overview

Job Title:
Senior QC Engineer

Reports to:

Associate Director, Quality Control

Location:

San Jose, CA (on-site)

The Senior QC Engineer is responsible for conducting quality control tests on reagents and instruments in compliance with applicable regulations and ISO 13485 standards. This role works independently on established assignments, following documented procedures with precision, and determines test processes on new assignments. The role collaborates with R&D to help establish new product criteria and test processes and communicates findings to management and other departments.

This position may present data in cross-functional meetings and during customer calls.

How this role drives the company forward:
The Senior QC Engineer contributes to ensuring that final products are safe, reliable, and meet specifications. The role involves maintaining and updating standard operating procedures (SOPs) and relevant documentation for each product, participating in troubleshooting experiments, analyzing data, and presenting findings to relevant team members. This role collaborates with the Research and Development team to develop QC-related processes for new products, leads process improvement projects, and participates in quality improvement activities.

The position may participate in internal and external audits and provide training to other team members.

What will you do:

• Responsible for testing assigned products.
• Chairs meetings coordinating cross-functional quality improvement projects related to product testing, acceptance QC criteria, vendor validation, and troubleshooting. Specific tasks depend on the product line.
• Review vendor-supplied test results to ensure compliance with product specifications.
• Facilitate resolution of quality issues by interacting with key personnel or vendors for OEM products.
• Implement quality procedures to optimize testing processes.
• Maintain records and follow good manufacturing practices and SOPs.
• Write and update QC work instructions, SOPs and other technical documents as needed.
• Make independent decisions on complex issues in collaboration with other team members and in alignment with company policies.
• Interact with various groups, share information and troubleshooting results, and participate in team activities.
• Remain flexible to support changing priorities with short notice.
• Assist in maintaining inventory accuracy through efficient management of product work orders and cycle count activities.
• Maintain stocked supply of communal reagents and materials.
• Serve 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 QC.
• Train Associate Quality Control Engineer or Quality Control Engineer as needed.
• Manage and drive resolution of quality issues with other departments with minimal supervision.
• This position does not have supervisory responsibilities.

How will you get here?

• Bachelor’s degree in a scientific discipline and a minimum of 8 years of hands-on experience in a life science or medical device/IVD industry in a laboratory quality role; or 6 years with a Master’s degree; or 3 years with a Ph.D.
• Practical experience in modern biochemistry and a strong background in quantitative methods.
• Experience in a BSL2 lab facility.
• Effective analytical and problem-solving skills, including attention to detail.
• Strong verbal and written communication skills.
• Ability to work independently, establish priorities to meet deadlines, and prepare clear written information.
• Strong planning, organizational, collaboration and communication skills with colleagues and external collaborators.

You are amazing if you have:

• Proficiency with computer programs such as Microsoft Office, File Maker, Adobe Acrobat, Arena, ERP systems, Jira.
• Prior experience in instrument automation.

AAP/EEO Statement: Takara Bio USA, Inc. does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors.

Additional Information about the role: This job description may not cover all duties or responsibilities required. Duties may change at any time with or without notice. The US base salary range for this full-time position, located in San Jose, CA, is $130,000 - $140,000 USD. This range may be modified at any time at our sole discretion. The base salary does not include additional bonus compensation and benefits.

Learn more about benefits at  Individual compensation packages are based on factors unique to each candidate, including job-related skills, training, experience, qualifications, work location, and market conditions.