Senior QC Engineer

Takara Bio USA•San Jose, CA

32d•$130,000 - $140,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.