Purpose and role of job:

Responsible for the management of the Quality Assurance Department’s operations and activities. 

Principal Accountabilities/ Responsibilities:

Administers and develops all aspects of quality systems in accordance with regulatory, industry, and customer standards.Serves as the Management Representative (Management Representative duties are described in the Quality Manual).Supervises the activities of assigned staff and monitors the activities of QA/QC personnel within the QA Department.Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality.Administers the quality audit program.Provides training to team members, as required, for implementing quality initiatives.Develops annual quality plans and recommendations for continual improvement in conjunction with the Operations Manager and Director of QA/RA.Determines methods and implements plans for professional development of personnel within the QA Department.Proposes budgets and monitors budget activity for the QA Department.Provides statistical analysis for evaluation of processes.Conducts lab tours and explains quality system to visitors.Completes required reports and summaries for regulatory & industry agencies.Observes all safety rules and uses the proper safety equipment at all times.Performs other duties as necessary when directed to do so.Follows necessary GMP, FDA, and ISO regulations.

Education and experience requirements:

Bachelor’s degree in an Engineering, Technology, Mathematics, Business, or Science discipline.Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment).Supervisory experience.Auditing experience in GMP and/or ISO systems.ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM).Advanced skills in oral and written communications.Standard skills in technical, business, and managerial fields.Standard skills in statistics, procedure implementation, and quality auditing.Competent in interactions with executive management, vendors, and customers.

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations.  As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.

First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.