Quality Engineer III - Medical Device (Onsite - Valencia, CA) Possible Contract Extension
Job
Pharmavise
Santa Clarita, CA (In Person)
Full-Time
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Job Description
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 techniquesMinimum 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 monthsPreferred 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 systemsOther Details:
Schedule:
08:00:AM - 04:30:
PM Work Setup:
Onsite inValencia, CA Contract Length:
12 Months (5/25/2026 - 5/25/2027) and Possible ExtensionSimilar remote jobs
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