CLASS TITLE: Manager of Quality
CHARACTERISTICS OF THE CLASS: Under general direction, develops, implements, and monitors the Corporate Quality System to ensure products manufactured and released by the Company conform to specifications and all regulatory requirements (e.g., FDA, UL, etc.); and performs related duties as required.
ESSENTIAL DUTIES: Develops, implements, and monitors the Corporate Quality System to ensure products manufactured and released by the Company conform to specifications and all regulatory requirements (e.g., FDA, UL, ISO, etc.). Recommends, develops and implements programs designed to improve the quality of Progeny products. Leads management review of the quality system and conducts periodic Management Reviews to ensure the suitability and effectiveness of the Quality System.
Develops, implements and monitors various performance metrics and key quality indicators. Develops, implements and controls production quality programs for the conformance of product systems, including such information as the number of units to be inspected/tested and the frequency and the methods to be used. Develops criteria and procedures for supplier evaluations and conducts audits to ensure that suppliers are providing goods and services in accordance with Progeny objectives and specifications.
Responsible for Corporate audit process, both internal and external. Acts as the liaison with external Quality System auditors and Regulatory bodies and prepares required responses and corrective action reports, as needed. Coordinates and leads internal audit program for compliance with FDA, cGMPs and International Quality Standards. Facilitates required inspections and audits.
Manages the Corrective and Preventive Action process to achieve compliance with internal procedures and external standards. Conducts nonconformance investigations, as needed. Performs quality related problem solving in regard to product issues, customer complaints and non-conformance issues. Communicates quality issues, as needed, throughout the organization.
Drives process and product improvement efforts and provides analytical assistance in assessing change.
Responsible for all incoming, in-process and final testing.
RELATED DUTIES: Maintains records and prepares reports. Assists in identifying the need for and developing methods for improving safety within the facility. Keeps abreast of current trends and practices in the quality area.
MINIMUM QUALIFICATIONS:
Training and Experience: A Bachelor’s degree in Engineering from an accredited college or university supplemented by at least seven years work experience in the Quality field; at least two years of which have been in a supervisory capacity. Or an equivalent combination of training and experience.
Knowledge, Abilities and Skills: Thorough understanding of FMEA, Design of Experiments, and Statistical Process Control. Working Knowledge of cGMPs and ISO. Working knowledge of Six Sigma and other process improvement methodologies.
Ability to analyze complex data utilizing appropriate statistical methods and programs and prepare reports. Ability to work well with all levels of the organization.
Strong leadership, analytical and interpersonal skills. Good written and verbal communication skills. Strong organizational skills. Strong computer skills
PHYSICAL REQUIREMENTS: Able to use a personal computer. Able to bend, reach, and occasionally lift up to 30 pounds.
Working Conditions: Office environment with occasional exposure to lab and manufacturing plant environment, which has some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
Progeny, Inc. • 675 Heathrow Drive • Lincolnshire, IL 60069
Tel: 888-924-3800 • 847-415-9800 • 847-415-9801 Fax
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