Quality Engineer III - Medical Device (Onsite - Valencia, CA) Possible Contract Extension Job at Pharmavise, Santa Clarita, CA

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  • Pharmavise
  • Santa Clarita, CA

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

Job Tags

Full time, Contract work, Work at office

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