Job Description

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.