Manager I, Quality

Key Duties and Responsibilities The 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.). Support and drive consistency of Premier Magnesia Quality Programs and procedures across all assigned areas of responsibility Plan and assign work of subordinates efficiently and effectively to ensure proper coverage and oversite Develop 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 solution Ensure appropriate collection and maintenance of all quality records and inspection reports Develop, initiate and adjust standards and methods for inspection, testing and evaluation Provide input to and support of the Material Review Board to ensure proper disposition of material and documenting associated Quality Costs Team Member development through leadership, performance reviews, coaching and feedback Owner of Customer Complaint Process and driver of Corrective/Preventive Action activities ensuring proper root cause, corrective activities and verification of actions prior to timely closure Maintain 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 Management Other projects or assigned responsibilities as business needs may require

Travel :

andnbsp; Little to no travel expected unless business needs require EDUCATION and/or

EXPERIENCE

Bachelor's degree in engineering or related industrial, scientific, or business management field required Minimum experience is 4+ years of related experience Minimum of 2 to 5 years' experience in a manufacturing environment preferred Experience with

FDA:

CFR 210/211

preferred

ISO 9001-2018

experience preferred Root cause analysis, analytical and problem-solving experience preferred Intermediate to advanced math and statistical skills Ability to communicate technical terms in common sense manner to all levels of organization and externally Strong organizational and information management skills required Solid base of knowledge with respect to Quality Management Software Ability to work in cross-functional teams Excellent project management skills Strong written and verbal communication skills Work will take place in an office and manufacturing environment. Employee may be required to work weekends, holidays and be on-call on occasion.andnbsp; The employee may encounter controlled air conditions with frequent air changes and environmental exposure. These are considered essential duties and are illustrative of those job tasks, which are fundamental.andnbsp; Employees may be required to perform additional related duties as they may be assigned by management.andnbsp; Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.