Description:
Onsite
Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. The client is not able to consider candidates who require sponsorship.
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, 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:
Experience inthe medical devicee industry
Familiarity with post-market requirements and systems
