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QUALITY ASSURANCE
DEPARTMENT: Quality
SUMMARY OF FUNCTIONS
Responsible for ensuring that all products manufactured are in accordance with the company's quality assurance program and quality/reliability standards that satisfy customer specifications and expectations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for the development, implementation and strict adherence to a quality assurance program. Develops and/or reviews standards, policies and procedures for all functions and departments involved with or related to the production of all products. The Director of Quality Assurance has the ultimate authority and decision over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards.
Reviews and resolves quality control problems/concerns with the Quality Control Manager and others including vendors, customers, quality control personnel and any personnel related to production. Coordinates and assists with vendor inspections.
Periodically inspects completed quality control checklists, forms and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards.
Schedules and performs quality assurance audits and reports findings to the President, Quality Control Manager and Vice President of Production and Operations; develops corrective action plans and oversees timely resolution.
Receives and reviews all customer satisfaction surveys and customer contacts and complaints. Reviews complaint trends and product/component failure analysis; reviews corrective actions with appropriate personnel.
Prepares reports and other documentation required by regulatory agencies and to support the quality assurance function.
QUALIFICATIONS
EXPERIENCE IN A GMP ENVIRONMENT A MUST. A college degree is required with a major in science or engineering preferred. Good communication skills and the ability to work well with people is essential. Good leadership skills are beneficial. Familiarity with statistical methods and spreadsheet applications is required.
PHYSICAL DEMANDS
Ability to communicate orally with customers, vendors, management and other co-workers is crucial. Regular use of the telephone and e-mail for communication is essential. Sitting for extended periods is common. Hearing and vision within normal ranges is helpful for normal conversations, to receive ordinary information and to prepare or inspect documents.
No heavy lifting is expected. Exertion of up to 10 lbs. of force occasionally may be required. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and FAX machines.
Good reasoning ability is required to solve a wide range of business problems. Able to apply statistical calculations, analysis of variance, correlation techniques, and sampling theory as well as algebra, linear equations, and other analytics as required. Able to understand and utilize Internet server and network reports to conduct business.
WORK ENVIRONMENT
The job is performed indoors in a traditional office setting. Activities include extended periods of sitting and extensive work at a computer monitor.
