Job Description

Direct HIre
Location: San Jose, Ca.
Salary: $95k - $105k per annum

The 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 may determine test processes on new assignments or products. The QC Engineer demonstrates a high level of documentation accuracy and clarity when recording results. This role exercises good judgement when resolving issues of diverse scope and communicates effectively to management and other departments when performing troubleshooting experiments or other quality related tasks.  This position may present data in cross-functional group meetings.
 
The QC Engineer is an on-site, lab-based role located in San Jose, CA.
 
 
How you will make an impact:
In this role, you will work to ensure the overall quality of control tests on reagents and instruments, confirming the final products are safe, reliable, and meet expectations. You will be working on maintaining and updating standard operation procedures (SOPs) and the relevant documentation for a product.
 
What will you do:

• 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 program
  To apply please email your resume to mjtgarcia@ledgent.com

Job Snapshot

• Employee Type:Full-Time
• Location:San Jose, CA
• Job Type:Biotech
• Experience:Not Specified
• Education:Not Specified
• Date Posted:3/24/2023
• Contact: Mark Garcia (408) 418-1867
• Pay Range: $95,000.00 - $105,000.00 Annually

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