Quality Engineer III — Medical Device (Onsite — Valencia, CA) Possible Contract Extension

Pharmavise Corporation · Valencia, United States · 1 month ago

Employment: Contract
Category: Industrial engineering
Experience: 4+ years

Job Summary:

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.

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

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

Other Details:

Schedule: 08:00:AM - 04:30:PM

Work Setup: Onsite in Valencia, CA

Contract Length: 12 Months (5/25/2026 - 5/25/2027) and Possible Extension

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