Technician, Pilot Quality

Edwards Lifesciences•Irvine, CA

About The Position

The Pilot Quality Technician provides technical and function-specific knowledge to support R&D and QA engineering activities. The role supports transfer builds, engineering studies, method-development activities, validation readiness, and inspection correlation between transferring and receiving sites. It performs detailed visual and dimensional inspections of components, subassemblies, and finished devices, operates inspection and measurement equipment, and documents results in controlled quality and manufacturing records. The technician is expected to learn new inspection systems, recognize equipment abnormalities, and escalate issues when needed.

Requirements

  • Associate's degree or equivalent, or a technical degree/certificate in a related field.
  • 1 year of related experience.
  • Good computer skills, including use of MS Office Suite.

Nice To Haves

  • R&D lab and/or medical device experience.
  • Electronics/sensor manufacturing and/or medical device experience.
  • Strong written and verbal communication, interpersonal, and relationship-building skills.
  • Moderate understanding of equipment in a lab environment.
  • Ability to identify problems and relevant issues in straightforward situations, assess them using standard procedures, and perform basic troubleshooting.
  • Ability to use manufacturing, test, development, or diagnostic equipment and tools such as measuring equipment.
  • Ability to read and understand procedures, drawings, and schematics, and carry out assembly instructions.
  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing.
  • Ability to work under close supervision.

Responsibilities

  • Support execution of transfer builds, engineering studies, method-development activities, validation readiness, and inspection correlation between transferring and receiving sites.
  • Perform detailed visual and dimensional inspections of components, subassemblies, and finished devices, identifying contamination, damage, dimensional nonconformance, and other defined failure modes.
  • Set up and operate inspection and measurement equipment, including microscopes, vision systems, dimensional measurement tools, and process-specific fixtures.
  • Execute inspections in accordance with approved Quality Inspection Procedures, Manufacturing Process Instructions, work instructions, drawings, and acceptance criteria.
  • Document inspection results, equipment information, lot and serial-number traceability, acceptance decisions, and supporting images in controlled quality and manufacturing records.
  • Learn new inspection systems, select appropriate settings and magnification, recognize equipment abnormalities, and escalate issues when needed.
  • Follow company rules and requirements, including Environmental Health & Safety rules, and take adequate control measures to prevent injuries and pollution.

Benefits

  • Competitive salaries
  • Performance-based incentives
  • A wide variety of benefits programs to address the diverse individual needs of employees and their families
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