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Edwards Lifesciences Inspector, Quality in Irvine, California

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:

• 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

What you'll need (Required):

H.S. Diploma or equivalent Preferred

2 years experience previous related experience Required

Previous medical device assembly experience Preferred

Experience in delivery system and implant Preferred

What else we look for (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

• Able to read, comprehend, speak, and write English

• Basic computer skills required, including working knowledge of manufacturing software

• 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

• Candidate will be required to pass basic English skills assessment

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 to $59,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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