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 more complex components and/or finished medical device products using a wide variety of tools and equipment to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity. Highlight and escalate work issues to LeadPerform functional testing of finished medical device products using both automated and manual valve testing equipmentPerform verification of quality records which include Device History Records review and/or product release for interplant shipment or distributionMay control inventory to ensure appropriate storage conditions and movementOther incidental duties: General work area housekeeping
Education and Experience:
Secondary Education Preferred
Other: 2 years experience previous related in manufacturing and QC experience Required
Additional Skills:Basic computer skills, requiredAbility to read, comprehend, and speak English, and good communication skills, requiredAbility to use applicable tools and equipment, hand-eye coordination, and high manual dexterityFull understanding of applicable inspection proceduresContinuously expands proficiency in inspection techniquesAbility to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)Strict attention to detailMust be able to work in a team environmentAbility to effectively provide and accept feedback from colleaguesAdhere 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