Job description

Assesses components and devices upon receipt to ensure regulatory and company guidelines have been met, and that the components and devices meet operational standards as designed.

Key Responsibilities:

• Perform visual, dimensional, and functional inspection of components and devices using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, calipers, etc. to ensure conformance with design specifications
• Perform verification of receiving documents with component and device drawings to ensure requirements are met
• Review, follow and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE.
• Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status.
• Train colleagues from other sites, including inspection of their work output
• Other incidental duties: General work area housekeeping, attend training for new processes and procedures

Education and Experience:
H.S. Diploma or equivalent Basic level of understanding of inspection procedures Preferred
no previous related experience Required

Additional Skills:

• Ability to use small hand tools, hand eye coordination, and high manual dexterity Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
• Ability to effectively provide and accept feedback from colleagues on independent data verification
• Good communication skills
• Able to read, comprehend, speak, and write English
• Basic computer skills, required
• 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 $37,000 to $50,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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