Quality Engineer III — Medical Device (Onsite — Valencia, CA) Possible Contract Extension
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
1-10 employees
