Quality Engineer II

Interview process: 2 rounds. 1st with the HM, second with a team panel. About This Role: Responsible for creating test work instructions, training, and mentoring technicians who work on investigation of return and non-return products. The QE will review results of investigations completed by others for accuracy, completeness, and compliance with 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. He/She will be responsible for creating monitoring IDs to assess product performance and investigate performance changes using data analysis tools to find the cause.

Your Responsibilities Will Include: Understanding failure modes and approving product analysis for return and non-return complaints related to electro-mechanical devices performed by technicians Coordinating, training, and supervising failure investigation activities for lab technicians Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, and Supplier to help determine the root cause of complaints Monitoring product performance and escalating any non-conformance issues with returned devices Creating, releasing new WI/SOPs in document control system Initiating and owning non-conformance investigations Training technicians to find the root cause of complaints through sound failure analysis techniques What We're Looking for in You:

Minimum Qualifications: Bachelor's degree in Electrical Engineering with 2+ years of relevant experience Demonstrated problem-solving & failure analysis capabilities of electronics systems/components, including those with RF communication Proficient with Microsoft Office tools including Word, Excel, Power Point, and Outlook Great written/verbal communication skills and ability to collaborate with other teams Ability to successfully multi-task and be adaptive

Preferred Qualifications: Experience inthe medical devicee industry Familiarity with post-market requirements and systems