- 183797 - Quality Engineer
- CA-Bay Area
- Santa Clara
- Up to $33.00 DOE
- 12 Months
- Chipton-Ross is seeking a Quality Engineer for an opening in Santa Clara, CA.
Perform software quality engineering activities for Microarray products in a Medical Device Industry.
Ensure that project requirements and deliverables for software quality sustaining activities are met.
Create and revise Quality Reports and Risk Assessments.
Ensure that product validation activities are compliant to applicable internal and external standards such as ISO 13485:2016 and MDSAP.
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 aligned with applicable regulations.
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 product 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
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.