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Our client is a leading contract manufacturer of high-performance, precision components for demanding medical device applications. They offer customers extensive global manufacturing expertise, by combining lean manufacturing and continuous improvement with advanced process technology. Their decades of DFM and lean-manufacturing experience provides our OEM partners a single-source solution - from design and development input through the manufacturing process to the flawess completion of a project ? adding value at every step.
Works within a manufacturing environment and is charged with developing, implementing, maintaining, and improving a quality system to assure that all products manufactured by the organization meet customer specifications and achieve superior quality, reliability, and value for the customer. Provide quality assurance support, guidance, and leadership to the company to achieve quality goals and objectives, and to promote and uphold the high expectations for quality and continual improvement.
DUTIES AND RESPONSIBILITIES
? Responsible for maintaining and improving established Quality Systems according to FDA 21CFR820 Quality System Regulation and ISO 13485 requirements to ensure that customer product quality and customer requirements are met. This includes responsibility as the management representative for the quality system.
? Collaborates and works closely with the General Manager and peer managers in Engineering, Manufacturing, Product Areas, and Purchasing to support manufacturing and activity to achieve quality goals and objectives.
? Ensures that the Quality Department is staffed at appropriate levels through planning, forecasting, developing manpower plans, and departmental budgets.
? Provides clear direction to direct reports and obtains results using a participative management style.
? Primary interface with customers with respect to all quality related issues, and quality systems audits.
? Responsible for proper coordination of the Correct and Preventive Action process for CAPA?s stemming from audits, customer complaints or other sources.
? Provides valuable input during contract review process related to ability to meet customer requirements, inspection methods and required inspection equipment.
? Prepares in preparation of quality plans, procedures, scheduling, staffing plans, etc.
? Assist product areas in maintaining control of non-conforming product including ensuring proper identification, inventory control, and quick disposition of suspect material.
? Coordinates the activities of Gage Calibration, Quality Engineering, Internal & Customer Audits.
SPECIFICATIONS (SKILLS AND ABILITIES)
? Strong interpersonal and presentation skills needed to interact with customers as well as with all levels within the company.
? Thorough knowledge of machine processes and statistical process control.
? Must demonstrate excellent writing skills with ability to prepare technical documentation.
? Thorough knowledge and experience surrounding quality control inspection equipment and methods, including calibration and fuctionality.
? 7+ years of Medical Device experience in a quality role.
? Bachelor?s Degree in an Engineering discipline
? Proven problem solving experience, including 8D
? Proven management and leadership skills.
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