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

Pharmavise Corporation
  • Valencia, California
    30+ days ago

    Job Description

    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




    Numbers & Facts

    LocationValencia, California
    Websitehttp://www.pharmavise.com

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