Job Position: Quality Assurance Manager
Location: Waynesville, NC 28786
Pay Rate: $85000.00-95000.00
Quality Assurance Manager
ESSENTIAL 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.).
-
Supports and drives consistency of 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: 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 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