at Waters Technologies Corporation in New Castle, Delaware, United States
Senior Quality Engineer
This individual is responsible for supporting the TA Instruments QMS Processes and the nonconforming product process within the New Castle Manufacturing facility. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, supporting product transfers into production, and driving improvement activities and projects related to product and process quality. Additional responsibilities include processing Internal and Customer Audit Findings. This includes driving improvement activities in these areas and collaborating on projects to harmonize activities across TA sites, chair of Material Review Board (MRB) and trending meeting. This position is hands-on in a fast-paced environment which will interact with multiple functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and other TA manufacturing sites.
Manage and Maintain Internal and External Audit Processes
Manage and Maintain Non-Conformance systems
Manage Quality systems by compiling quality data, performing and supporting audits, reviewing non-conformances ensuring root cause analysis are completed.
Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system.
Reporting key performance metrics for reporting and developing process improvements.
Qualified individual should have a bachelor's degree in engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineer, etc.), Business, Mathematics, Science, or technical field with emphasis on statistical skills. Advanced degree preferred.
* Minimum 3 years of experience in Quality Assurance or related field.
* Good report writing and reviewing skills
* Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T), along with electrical and fluidic schematics.
* Project management skills, exceptional organizational and time management skills, attention to detail, critical thinking and problem-solving skills, and commitment to client satisfaction are essential.
* Working experience and knowledge of quality management systems in ISO13485 or ISO9001
* Analytical thinker and problem solver
* Experience using Sparta Trackwise or other electronic QMS systems
* Ability to work independently across multiple organizations.
* Demonstrated implementation of continuous improvement methodologies
* ISO13485 / ISO 9001 / cGMP knowledge base
* Operational Excellence/Six Sigma/Lean training or certifications
* Experience using Smartsheets and Power BI
* Experience in a electromechanical manufacturing facility
* Experience using Smartsheets, Power BI and Sparta Trackwise
* Experience using SAP or Oracle
* Experience supporting the manufacture of complex electromechanical assemblies
* Good report writing and reviewing skills
* Knowledge of various quality systems
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal... For full info follow application link.
Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.