QA Specialist – Medical Device

Role: QA Specialist responsible for ensuring quality compliance on the manufacturing floor and supporting batch release activities. Responsibilities include conducting audits and checks of incoming and in-process materials, verifying regulatory adherence, performing inspections for Safe Launch and Exit, reviewing batch records, approving deviations, investigating issues, and assisting with training and additional quality functions. The role also involves supporting the kitting area as needed. Requirements: 0-2 years in Quality Assurance, Manufacturing, or regulated industries; knowledge of cGMPs and regulatory standards for medical devices; proficiency in Microsoft Office; strong communication, organizational, and independent work skills; physical ability to stand for hours, lift ~20 lbs, and handle pallet activities. Preferred qualifications are not specified. HighValue: Medical device manufacturing, cGMP compliance, batch record review, regulatory adherence, inspection and audit skills, and supporting quality assurance functions on the production floor. Work setup: onsite in Johnson City, TN, Monday-Friday, 8 AM-4:30 PM.