Quality Engineer II - Medical Device (Onsite - Valencia, CA) Possible Contract Extension

Job Description Job Summary:

Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R D, Design Assurance, Operations, Supplier Management, and Medical Safety.

Responsibilities will include:

Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians Coordinating, training and supervising failure investigation activities for lab technicians Support integration of new products into CIS lab by creating/validating test methods and test instructions Creating and presenting slides for SER/CRB Collaborating with other Post Market (CCC/CMC) teams, R D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints Monitoring product performance and escalating any non-conformance issues with returned device. Creating, releasing new WI/SOPs in document control system Initiating and owning non-conformance investigations Training technicians to find root cause of complaints through sound failure analysis techniques

Minimum Qualifications:

Bachelor's degree in Mechanical Engineering with 2+ years of relevant experience •Bachelor's degree can be in electromechanical/electrical but the candidate needs to have hands-on experience in failure analysis. Demonstrated problem-solving & failure analysis capabilities of mechanical systems/components Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook Great written/verbal communication skills and ability to collaborate with other teams Ability to successfully multi-task and be adaptive

Preferred Qualifications:

Masters degree in Mechanical Engineering with at least 1 year experience in similar role Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components Experience in Medical Device industry Familiarity with Post Market requirements and systems Familiarity complaint systems used for medical devices Experience with using

SAP and PowerBI Other Details:

Schedule:

08:00:

AM - 04:30:

PM Work Setup:

Onsite in

Valencia, CA Contract Length:

12 Months (5/25/2026 - 5/25/2027) and Possible Extension