Sr. Quality Assurance & Regulatory Affairs Manager
POSITION SUMMARY
The Sr. Quality and Regulatory Manager will provide overall company leadership and direction for 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 + $40 million in annual sales. The role requires the above to be accomplished within Tecomet principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
PRINCIPAL RESPONSIBILITIES
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. The objective is to devise systems that facilitate good products fast without compromise.
- Assure Tecomet 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’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.
- Performs other duties or special projects as required or as assigned by supervisor.
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
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED
- Strong organizational skills
- Strong people and leadership skills
- Diplomacy
- Motivation
- Teaching/Coaching/Mentoring
- Verbal and written communication and listening skills
- Highly Proficient in Microsoft Office
- Problem solving and evaluation
- Process improvement
- Project management
- ISO 13485/EN46001
- ISO 14001
- Federal and State laws and regulations
- Knowledge of International Quality Standards
- Knowledge of International Environmental Standards
- Strong auditing background
- Speak in front of people in a variety of settings
- Be flexible and adapt to changes in the marketplace
- Create and manage high performing work teams
- Interface professionally and courteously with customers/public/internal staff
- Prioritize work
- Meet goals and objectives set for the company
- Make decisions in a consistent, professional
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