Inspector

Edwards Lifesciences•Irvine, CA

29d•Onsite

About The Position

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. 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. Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.

Requirements

2 years previous related experience required
Able to read, comprehend, speak, and write English.
Candidates will be required to pass a basic English skills assessment.
Basic computer skills required, including working knowledge of manufacturing software.

Nice To Haves

H.S. Diploma or equivalent preferred
Previous medical device assembly experience preferred
Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity
Basic level of understanding of inspection procedures
Ability to effectively provide feedback on product defects and may follow through to establish resolution
Good communication skills
Strict attention to detail
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Must be able to work with minimum supervision
Work in a Team environment
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

Responsibilities

Performing visual, dimensional, and functional inspection of more complex components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications – working at a level of greater independence with a higher level of productivity.
Performing functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications.
Reviewing, following and performing job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
Performing verification of manufacturing documents with component and device drawings.
May control inventory to ensure appropriate storage conditions and movement.
May train colleagues from other sites, including inspection of their work output.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
Other incidental duties: General work area housekeeping.

Benefits

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.

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