Manage the organization and distribution of electronic and paper drawings, reports, parts lists, and specifications. Manages one or more teams of Quality Technicians and/or Production Control Clerks. Ensures that the company’s products meet total quality management, ISO standards, FDA and other reliability standards. Researches and implements new or improved testing methods, processes, tools, and systems. Works closely with Customer’s, Manufacturing Engineering, Production and Customer Relations to develop and coordinate appropriate test procedures. Responsible for ISO compliance system, FDA and Q.S.R. requirements, coordinate the implementation, training and the continuing improvement provided in these processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Supervise the quality activity on the floor maintaining compliance to quality plans assuring operators understand quality requirements.
· Secure all quality requirements from customers, ensuring quality plans match.
· Maintain correct revision level of all documentation in documentation files and ERP system.
· Perform and coordinate with Manufacturing First Article, PQ/IQ work, securing approval from the customer to proceed.
· Create quality plans, develop measuring methods and supervise the accuracy of customers’ specification keeping all Manufacturing Plans up to date.
· Material Review Board (MRB) with final authority for disposition of non-conforming items.
· Compile and analyze inspection data for accuracy and function on the floor. Train operators in the accurate use of measuring tools.
· Maintain calibration on all instruments used for measuring and testing of all products.
· Measure parts during production to ensure compliance with design specifications.
· Maintain correct documentation level, disposition of obsolete drawings and specifications.
· Participate in weekly, monthly and annual management meetings, contributing to new business and company activity. Recording minutes per I.S.O. procedure. Prepare monthly reports on I.S.O. corrective actions and new standards.
· Responsible for the accuracy and updates to the Quality Manual
· Responsible for the supervision of the quality system to adhere to all regulatory requirements.
· Approve Certificate of Compliance forms prior to shipping.
Skills, and Environment
Education and Work Experience
Bachelor's degree preferred; may have advanced degree. Usually requires 5 to 7 years of experience in manufacturing quality or operations with 3 years of experience directly related to quality and at least one year of leadership experience.
Knowledge and Skills
Proven experience in leading manufacturing quality projects. Excellent knowledge of manufacturing quality processes and procedures. Excellent time management, communications, decision making, presentation, human relations and organization skills. Able to resolve problems in a timely manner. ISO certified training, TQM or other specific quality training or certification.
Environment and Physical Demands
General office environment and manufacturing environment. Exposure to hazards associated with manufacturing equipment and tools. Some physical demands.
Upon converswion to a full time employee:
Full benefits, medical, dental, vision with employee paying a portion. Simple IRA, vacation.