POSITION: Quality Engineer III
FULLTIME: 12-Month Assignment (Possible Extension)
LOCATION: Valencia, CA
TRAVEL: San Diego, CA (following training in Valencia, CA then 4–5 days onsite for several months in San Diago- hotel covered expense)
INTERVIEW PROCESS: 1st: phone screen 2nd: onsite or teams interview
SCHEDULE: 40/HRS
PAY RANGE: $60 HR
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)
JOB DESCRIPTION:
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 result 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 the product performance and investigate performance changes using data analysis tools to find cause.
Your Responsibilities Will Include:
• Providing leadership role on championing departmental or cross-functional engineering initiatives
• 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
• 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 devices
• Creating and maintaining of product performance trends based on UPN and code groupings.
• Investigating trend excursions by doing data analysis to find cause
• 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
What We're Looking for in You:
Minimum Qualifications
• Bachelor’s degree in Electrical Engineering with 4+ 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
• Understanding of RF communication scheme/concepts
• Requires working in San Diego for a few months
Preferred Qualifications
• Masters degree in Electrical Engineering with 2-3 years’ 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
Working Conditions: