TITLE
: Director Quality Assurance & Reg. Affairs Systems – Worldwide
Department:
Quality
Classification:
Exempt
Reports To:
Exec. V.P. Quality Assurance & Regulatory Affairs
JOB 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, create, monitor and improve quality systems/programs, reduce quality costs and maintain 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), design for world-class 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 cost 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 the profit margins for Tecomet Medical. The objective is to devise systems that facilitate good products fast without compromise.
- Assure Tecomet Medical is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.
- Provide organizational assessments to upper management.
- Enhance the one company systems interface capabilities, whereas optimizing the capabilities to perpetuate harmonized systems improvements, and based on deploying the best practices from the collective experience contribution of the worldwide teams.
- Ensure the quality systems focus remains on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.
- Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently 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.
- Master’s degree (desirable but not essential)
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