Tecomet
Director of Quality Assurance & Regulatory
Tecomet, Warsaw, Indiana, United States, 46580
Tecomet Director of Quality Assurance & Regulatory Warsaw, Indiana Apply Now
TITLE:
Director Quality Assurance & Reg. Affairs Systems – WorldwideDepartment:
QualityClassification:
ExemptReports To:
Exec. V.P. Quality Assurance & Regulatory AffairsJOB SUMMARY:Provide overall company leadership and direction for worldwide Tecomet Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, creating, monitoring, and improving quality systems/programs, reducing quality costs, and maintaining compliance within FDA and ISO regulations for +$500 million in annual sales. This is accomplished by maintaining Tecomet's principles of Safety, Quality, Customer Satisfaction, and Innovations.ESSENTIAL FUNCTIONS:Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), and design for manufacturability.Take a leadership role as a Sr. Director and mentor supporting functional team members.Integrate the quality function with manufacturing as a value-added (real-time) support function, optimizing the continuous quality improvement process while reducing costs and improving customer relationships.Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity, and maximize profit margins for Tecomet Medical.Assure Tecomet Medical is conducting business within compliance with regulations as cost-effectively and efficiently as possible.Provide organizational assessments to upper management.Enhance the one company systems interface capabilities, optimizing the capabilities to perpetuate harmonized systems improvements based on best practices from worldwide teams.Ensure the quality systems focus remains on continual quality improvement, aligned with internal and external customer expectations.Ensure the organization is basing improvement-related decisions on factually meaningful data, reducing waste and expediting the recognition of favorable results.Leadership responsibility for promoting and developing Tecomet Medical’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.EDUCATION AND WORK EXPERIENCE:Bachelor of Science in Engineering (ME, IE, BME) required.Six Sigma Black Belt certification ( desirable but not essential ).Seven (7) to ten (10) years of quality engineering experience directly in new product development of medical devices is required.
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TITLE:
Director Quality Assurance & Reg. Affairs Systems – WorldwideDepartment:
QualityClassification:
ExemptReports To:
Exec. V.P. Quality Assurance & Regulatory AffairsJOB SUMMARY:Provide overall company leadership and direction for worldwide Tecomet Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, creating, monitoring, and improving quality systems/programs, reducing quality costs, and maintaining compliance within FDA and ISO regulations for +$500 million in annual sales. This is accomplished by maintaining Tecomet's principles of Safety, Quality, Customer Satisfaction, and Innovations.ESSENTIAL FUNCTIONS:Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), and design for manufacturability.Take a leadership role as a Sr. Director and mentor supporting functional team members.Integrate the quality function with manufacturing as a value-added (real-time) support function, optimizing the continuous quality improvement process while reducing costs and improving customer relationships.Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity, and maximize profit margins for Tecomet Medical.Assure Tecomet Medical is conducting business within compliance with regulations as cost-effectively and efficiently as possible.Provide organizational assessments to upper management.Enhance the one company systems interface capabilities, optimizing the capabilities to perpetuate harmonized systems improvements based on best practices from worldwide teams.Ensure the quality systems focus remains on continual quality improvement, aligned with internal and external customer expectations.Ensure the organization is basing improvement-related decisions on factually meaningful data, reducing waste and expediting the recognition of favorable results.Leadership responsibility for promoting and developing Tecomet Medical’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.EDUCATION AND WORK EXPERIENCE:Bachelor of Science in Engineering (ME, IE, BME) required.Six Sigma Black Belt certification ( desirable but not essential ).Seven (7) to ten (10) years of quality engineering experience directly in new product development of medical devices is required.
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