Edwards Lifesciences Corp Salt Lake City , UT 84101
Posted 5 days ago
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:
Assign work to lower level employees ensuring balanced work along lines and across shifts, which may include establishing work schedules
Perform visual, dimensional, and functional inspection across all components and/or finished medical device products using all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications - working independently at the highest levels 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, which may include Geometric Dimensioning and Tolerancing methodologies
May control inventory to ensure appropriate storage conditions and movement
Train colleagues from other sites, including inspection of their work output
Provide coaching and training to lower level employees and colleagues; Identify and escalate work issues and able to fill-in for Supervisor as needed
Other incidental duties: General work area housekeeping
Education and Experience:
H.S. Diploma or equivalent Preferred
2 years experience Specifically in sewing, GMP, clean room, medical device environment Required
Additional Skills:
Demonstrated ability to lead teams, coach others, and transfer knowledge
Ability to use all applicable tools and equipment, hand eye coordination, and high manual dexterity
Full understanding of applicable inspection procedures, including the ability to contribute to and support the development of procedures
Proficient in all inspection techniques for production inspection
Ability to provide performance feedback, confirm understanding, and have a positive impact on competency and output of other inspectors
Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
Ability to program and contribute to the validation of automated test equipment
Strong communication skills and interpersonal relationship skills, including ability to convey training in methodology and procedures
Ability to serve as a role model to lower level inspectors in proper execution of day-to-day inspection duties as well as guide other workers/colleagues in understanding operations and quality standards
Strong English language skills, including reading, comprehending, speaking and writing, and strong communication skills
Proficient computer skills, including strong 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
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.
Edwards Lifesciences Corp