Quality Engineer II

TALENT Software Services; Santa Clarita (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

TALENT Software Services is seeking a Quality Engineer (Electrical) onsite in California to lead investigations of return and non-return devices and mentor technicians. You will develop test work instructions, monitor product performance, and collaborate across Post Market, R&D, and Design Assurance to determine root causes.

Responsibilities include coordinating failure investigations, creating WI/SOPs, and training staff in robust failure analysis techniques.

Qualifications

• Bachelor’s degree in Electrical Engineering and 2+ years of relevant experience.
• Strong problem-solving and failure analysis skills for electronics systems, including RF.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Excellent written and verbal communication with cross-team collaboration.
• Ability to multi-task and adapt in a dynamic environment.

Responsibilities

• Understand failure modes and approve product analysis for return/non-return complaints of devices.
• Coordinate, train, and supervise failure investigations for lab technicians.
• Collaborate with Post Market, R&D, Design Assurance, Manufacturing, and Suppliers to identify root causes.
• Monitor product performance and escalate non-conformance with returned devices.
• Create and release new WI/SOPs in document control system.
• Initiate and own non-conformance investigations.
• Train technicians to perform root-cause analysis of complaints.

Skills

Problem-solving

Failure analysis

Electrical systems

RF communication

Written/verbal communication

Team collaboration

Education

Bachelors in Electrical Engineering

Tools

Microsoft Office

Job description

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