Edwards Lifesciences 1st Shift Inspector – Quality in Irvine, California
Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.
Perform 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.
Perform functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications.
Review, follow and perform 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.
Perform 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.
H.S. Diploma or equivalent preferred.
2 years of previous related experience required.
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.
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 EHS rules and requirements 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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.