Job Listing Description

Quality Engineer

Chipton-Ross is seeking a Quality Engineer for an opening in Santa Clara, CA.

Ensure that project requirements for software quality engineering sustaining activities are met.
Perform software quality engineering activities for Microarray products in a cGMP environment.
Create and revise Quality Software Reports and Risk Analysis.
Ensure that software validation activities are compliant to applicable internal and external standards.
Coordinate Software Complaint review and closure.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving software quality issues.
Follow applicable site and global procedures and ensure that developed validations and respective specifications are accurate with cGMP process.
Archive, store and maintain all document files to comply with Corporate and Site policies in a state of audit readiness.
Work cross departmentally to address software quality issues.
Manage new staff additions to Learning Management System (LMS), user account maintenance, LMS update assessments, and issue monthly training reports.
Review and reporting of open CAPAs and deviations Monitor and report on project needs and respond in a timely manner for problems.

5-10 years of experience in Quality Software Engineering and Validation
Experience with Quality Software Engineering design and development processes and Validation in a cGMP and regulated industry
Experience with Quality Management Systems under ISO 13485:2016 / MDSAP or related Standards.
Solid communication and interpersonal skills.
Good organization and multi-tasking skills, drive for results and complete work on time
Working conditions: Works primarily in an office environment

Accredited B.S. degree in IT, Engineering, Technical or related field

1st Shift

Job Number: 183797
Job Location: Santa Clara, CA
Rate: Up to $33.00 DOE
Duration: 12 Months
Input Date: 02/07/2020
Last Updated: 02/07/2020
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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