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Lead Inspector

3 months ago

Salt Lake City, United States Edwards US Full time

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