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

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

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

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