This is an opportunity for a Leader in Quality with Med Device and Aerospace/DOD industry experience. You will have much opportunity to lead audits with the FDA. You will partner with customers and interface with vendors. Your strong communication skills will be very valuable in this role as will your knowledge of ISO 13485 , 9001 and 1310o.
Key activities include:
- 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. Manager 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.
- Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.
- 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’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.
EXPERIENCE AND EDUCATION REQUIRED
- Bachelor of Science in Engineering
- 5+ years of Quality Engineering experience within a manufacturing environment
- 2+ years of experience related to working within a regulated environment is preferred.
- 3+ years working directly with New Product Development and/or related launches
