The Quality System Manager is responsible for ensuring environmental and quality compliance by conducting research, analyzing data, directing the quality assurance program, providing technical support, managing the Quality team, and promoting continual improvement within the company's quality systems and standards.
ESSENTIAL DUTIES, FUNCTIONS, AND RESPONSIBILITIES
Plan, coordinate, and direct the quality assurance program to ensure products meet established standards.
Promote and execute quality systems, standards, inspection processes, and test methodologies.
Develop, execute, and analyze quality reporting measures and manage quality system issues.
Provide technical support and guidance for product production, including documentation, process flow charts, and raw material specifications.
Ensure compliance with applicable regulations, including FDA and ISO standards.
Analyze data to determine the root causes of problems and implement solutions.
Handle multiple tasks efficiently with effective time management skills.
Understand and promote the Quality System as part of the company's commitment to continual improvement and adherence to policies and procedures.
Act as the primary Management Representative for ISO and the company Quality System.
Participate in design development projects to represent Quality Systems.
Design, document, and implement methods for process control, improvement, testing, and inspection.
Report on quality system issues, trends, and losses to management.
Provide direction and support for internal Quality System development and maintenance.
Interface with the quality team on quality system problems.
Hire, train, and manage the Quality team, including handling promotions, demotions, transfers, and terminations.
Address product deficiencies, track corrective actions, and ensure timely and accurate customer communication.
Assist or lead internal and external audits and provide quality assurance training.
Determine product disposition and evaluate retained, returned, and released products.
Review and ensure accuracy of final release documents and customer complaints.
Verify product quality through daily control sheets and Quality shipping logs.
Guide laboratory personnel on quality and product/processes and support technical development activities.
Manage and control quality documents and maintain accurate inventory related to product release.
Perform any other related duties as assigned.
Exhibit exemplary attendance and punctuality.
Based on the essential duties listed above, this position is considered safety-sensitive and therefore all work must be performed following quality standards and established safety procedures.
EDUCATION & RELATED EXPERIENCE
A bachelor’s degree or higher in science or a related field is required.
Experience with quality principles and the interpretation and application of quality standards of industry regulations (e.g., ISO 9001) is required.
