Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.
Key Responsibilities:
• Perform visual, dimensional, and functional inspection of 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
• 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
• Other incidental duties: General work area housekeeping
Education and Experience:
H.S. Diploma or equivalent 0 years experience No previous related exp. required Preferred
Additional Skills:
• 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 and accept feedback from colleagues
• Good communication skills
• Able to read, comprehend, speak, and write English
• Basic computer skills, preferred
• 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.
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