Description
Job Requirements:* Four year college degree in a technical discipline such as Engineering, Science, or Mathematics, along with a minimum of five years experience in Quality in manufacturing environment
* Minimum two years of management experience
* Strong statistical analysis skills
* Design of Experiments knowledge and experience
* Experience acting as a change agent
* Ability to communicate on all levels both verbally and in written communication
* Knowledge of Quality Systems, the FDA Good Manufacturing Practices, and Statistical Process Control are required
* ASQC Quality Manager/Quality Engineer certification desirable
* Experience with the ISO 13485 Standard desirable
* Black Belt certification preferred
* Exposure or participation in Operational Excellence activities is beneficial (Continuous improvement, 5S, Lean, etc)
Job Responsibilities:
* This position has responsibility for people in, and services provided by, the Quality and Regulatory Management Department in the Mundelein facility. This also involves effective interactions with all departments at all levels to ensure continuity of good quality products and services, support introduction of new products as well as the qualification of new and changed supplied materials and processes. It is the function of the Q&RM Department to ensure that the facility is in compliance with FDA regulations relative to medical device manufacturing, and that the Company's quality procedures and systems are in compliance with the quality system requirements. Duties include:
* Managing nonconformities and CAPA system including
o Reviewing in-process quality failures and determining the disposition of non-conforming material
o Corresponding with customers and suppliers to resolve problems
* Problem-solving, root-cause analysis when appropriate
* Develop and implement quality and inspection plans with methods which are effective and cost beneficial
* Keeping informed of regulatory law changes and initiating appropriate action within the Mundelein facility to ensure compliance
* Corresponding with the FDA to resolve regulatory problems
* Train and develop the Quality and Regulatory Management staff
* Engage with customers and vendors on a regular basis
* Possess a working knowledge of customer requirements by spending hands-on time with production of products to assure appropriate product dispositions
* Collecting and analyzing performance data and charts against set indicators and parameters
* Define and implement quality initiatives and programs that would lead up to meeting Company quality goals and objectives
* Coordinating and hosting customer audits
To find out more about Real please visit www.realstaffing.com