Quality Manager

4 weeks ago


Waynesville, United States Premier Magnesia Full time

ESSENTIAL DUTIES AND RESPONSIBILITIESThe Quality Manager needs a solid understanding of all processes (from raw materials to finished product) and ability to apply understanding of FDA regulations (21 CFR 10/11, 21 CFR 820) and other regulatory requirements (HACCP, FSMA, TSCA, etc.).Supports and drives consistency of Premier Magnesia Quality Programs and procedures across all assigned areas of responsibilityPlan and assign work of subordinates efficiently and effectively to ensure proper coverage and oversiteDevelop and/or adapt inspection equipment or processes to meet quality control standards, make suggestions regarding procedures, standards and equipment to facilitate work and maintain product quality.Analyze facts or circumstances surrounding individual problems or incidents of nonconformance to determine appropriate actions to be taken within the limits of standard practices and with a strong command of root cause analysis and a cross-functional mindset to reach effective problem solutionEnsure appropriate collection and maintenance of all quality records and inspection reportsDevelop, initiate and adjust standards and methods for inspection, testing and evaluationProvide input to and support of the Material Review Board to ensure proper disposition of material and documenting associated Quality CostsTeam Member development through leadership, performance reviews, coaching and feedbackOwner of Customer Complaint Process and driver of Corrective/Preventive Action activities ensuring proper root cause, corrective activities and verification of actions prior to timely closureMaintain cGMP standards in compliance with regulatory requirements such as FDA, UL, Safe-Feed-Safe-Food, Kosher, Omri, etc.Support, utilize, train and optimize Quality Management Software (Master Control), specifically related to Document Control, Audit and Risk ManagementOther projects or assigned responsibilities as business needs may requireTravel:Little to no travel expected unless business needs requireEDUCATION and/or EXPERIENCE:Bachelor's degree in engineering or related industrial, scientific, or business management field requiredMinimum of 2 to 5 years' experience in a manufacturing environment preferredExperience with FDA: CFR 210/211 preferredISO 9001-2018 experience preferredRoot cause analysis, analytical and problem-solving experience preferredIntermediate to advanced math and statistical skillsAbility to communicate technical terms in common sense manner to all levels of organization and externallyStrong organizational and information management skills requiredSolid base of knowledge with respect to Quality Management SoftwareAbility to work in cross-functional teamsExcellent project management skillsStrong written and verbal communication skillsWork will take place in an office and manufacturing environment. Employee may be required to work weekends, holidays and be on-call on occasion.The employee may encounter controlled air conditions with frequent air changes, environmental exposure. These are considered essential duties and are illustrative of those job tasks, which are fundamental.Employees may be required to perform additional related duties as may be assigned by management.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


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