Technician, Pilot Quality

Edwards Lifesciences; Irvine (CA); On-site; USD 44,000 - 63,000; Full time

Job summary

Edwards Lifesciences Irvine site is seeking a Pilot Quality Technician to support R&D and QA engineering activities. You will perform transfer builds, inspections, and documentation to ensure product readiness and traceability across the lifecycle.

The role requires an Associate's degree (or equivalent) and at least 1 year of related experience, with strong MS Office skills and the ability to learn new inspection systems in a regulated medical device environment.

Qualifications

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

Responsibilities

• Support transfer builds, engineering studies, method-development activities, validation readiness, and inspection correlation between transferring and receiving sites.
• Perform detailed visual and dimensional inspection of components, subassemblies and finished devices, identifying contamination, damage and nonconformances.
• Set up, operate, and perform operations on inspection/measurement equipment (microscopes, vision systems, dimensional tools, fixtures).
• Execute inspections per approved Quality Inspection Procedures and drawings.
• Document inspection results, equipment information, traceability, acceptance decisions, and images in quality records.
• Escalate issues when needed and learn new inspection systems.

Skills

Good computer skills

Education

Associate's degree or equivalent in related field

Tools

MS Office Suite

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Pilot Quality Technician provides technical and function-specific knowledge to support R&D/QA engineering activities.

How you'll make an impact:

• Support execution of transfer builds, engineering studies, method-development activities, validation readiness, and inspection correlation between the transferring and receiving sites.
• Perform detailed and complex visual and dimensional inspection of components, subassemblies, and finished devices, identifying contamination, damage, dimensional nonconformance, and other defined failure modes.
• Set up, operate, and perform operations on 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.
• Accurately document inspection results, equipment information, lot and serial-number traceability, acceptance decisions, and supporting images in controlled quality and manufacturing records.
• Demonstrate strong equipment aptitude, including the ability to learn new inspection systems, select appropriate settings and magnification, recognize equipment abnormalities, and **escalate issues when needed**.

What you'll need (Required):

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

What else we look for (Preferred):

• 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, assessing using standard procedures and perform basic troubleshooting.
• Ability to use manufacturing, test, development or diagnostic equipment; use tools such as measuring equipment.
• Ability to read and understand procedures, drawings, 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.
• Must be able to work under close supervision.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $44,000 - $63,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.