Job Description
Job Description
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 I new product development of medical devices is required.
- Master’s degree ( desirable but not essential )
Senior Manager/Associate Director of Regulatory Strategy
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. You will collaborate closely with cross-functional teams, including Clinical Development, Medica...
Director of Regulatory Affairs
They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision. Lead the preparation and submission of high-quality regulatory dossiers and clinical trial applications, collaborating cross-functionall...
Senior Manager Regulatory Affairs and Quality Assurance
As Senior Manager of Regulatory Affairs and Quality Assurance you will be working collaboratively with other areas of the business, such as, Manufacturing, Sales, and R&D. Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique I...
Associate Director, Quality Assurance Information Systems Management - R&D
Associate Director, Quality Assurance Information Systems Management - R&D page is loaded Associate Director, Quality Assurance Information Systems Management - R&D Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-21527. This role ensures ri...
Senior Director, Quality Assurance (QA13-7)
Director of Quality to lead Quality Assurance for in-house and virtual GMP operations supporting the company’s novel TCR-engineered T cell therapy products. Our brand-new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camarad...
Director of Regulatory Affairs & Quality
The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. You have a minimum of 10 years’ experience working in R...
Director, GCP Clinical Quality Assurance
GCP Clinical Quality Assurance (CQA) oversight: Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, continuous improvement, and quality system procedural documents. We believe in helping people be their best and are seeking to bring togethe...
Director of Pharmacovigilance Quality and Alliance Management
The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV)team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology. Lead and mentor a team of pharmacovigilance and quality professionals, fost...
Director of Quality Management-Metro Boston Area
Demonstrated knowledge of regulatory standards, quality management, quality assurance, and risk management methods and techniques. Director of Quality Management. This is a unique opportunity to play an essential role in ensuring the delivery of high-quality, culturally competent services that suppo...
Quality Assurance Manager - AML/GFC
The Quality Assurance Team is responsible for ensuring that Corporate Audit activities comply with internal policies and procedures, as well professional standards set forth by industry and regulatory institutions. Subject matter expertise of BSA/AML and Fraud related risks with a focus on data, dat...