Quality Engineer III — Medical Device (Onsite — Valencia, CA) Possible Contract Extension
Pharmavise CorporationAbout the role
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:
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Providing leadership role on championing departmental or cross-functional engineering initiatives
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Understanding failure modes and approving product analysis for return and non-return complaints related to electro-mechanical devices performed by technicians
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Coordinating, training and supervising failure investigation activities for lab technicians
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Support integration of new products into CIS lab by creating/validating test methods and test instructions
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Creating and presenting slides for SER/CRB
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Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints
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Monitoring product performance and escalating any non-conformance issues with returned devices
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Creating and maintaining of product performance trends based on UPN and code groupings.
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Investigating trend excursions by doing data analysis to find cause
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Creating, releasing new WI/SOPs in document control system
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Initiating and owning non-conformance investigations
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Training technicians to find root cause of complaints through sound failure analysis techniques
Minimum Qualifications:
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Bachelor’s degree in Electrical Engineering with 4+ years of relevant experience
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Demonstrated problem-solving & failure analy
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