2nd Shift Inspector

Edwards Lifesciences•Irvine, CA

1d•Onsite

About The Position

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. How you'll make an impact: • The hours for this role are Monday-Friday 1:30-10:00pm. • 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.

Requirements

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

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.
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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