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

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