Description

Position Summary:

Manage all company quality policies, procedures, processes, programs, and practices to assure continuous conformance with appropriate standards and regulations. Responsible for regular quality audits and keeping the company in conformance with ISO certificate standards. 

Essential Functions: 

• Identify quality problems and recommend solutions. 
• Supply quality control data necessary for regulatory submissions. 
• Write or revise standard quality control operating procedures. 
• Participate in internal assessments and audits as required. 
• Promote quality achievement and performance improvement throughout the organization. 
• Implement, communicate and maintain a quality plan to bring the company’s Quality Systems and Policies into compliance with national and ISO certificate requirements. 
• Work with purchasing and customer service teams to establish quality requirements from external suppliers. 
• Monitor performance of quality control systems to ensure effectiveness and efficiency. 
• Create and implement quality inspection criteria and procedures. 
• Perform duties as the Document Coordinator, controlling revisions and access to controlled documents.
• Manage the KPI program and present to senior management.
• Manage the CAPA program to drive improvements across all departments.
• Monitor warehouses and equipment for environmental requirements to include calibration.

Requirements

Position Qualifications:

• Accountability - Ability to accept responsibility and account for his/her actions.
• Analytical Skills - Ability to use thinking and reasoning to solve a problem.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Communication, Written - Ability to communicate in writing clearly and concisely.
• Detail Oriented - Ability to pay attention to the minute details of a project or task.
• Ethical - Ability to demonstrate conduct conforming to a set of values and accepted standards.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
• Strategic Planning - Ability to develop a vision for the future and create a culture in which the long range goals can be achieved.
• Training - Ability to develop a particular skill in others to bring them up to a predetermined standard of work performance.

Education & Experience:

Education : Bachelor's Degree

Experience: One to two years related experience 

Computer Skills: Must be proficient in Microsoft Office, know how to use the Internet for research, as well as adapt easily to new systems.