at TA Instruments in New Castle, Delaware, United States
Quality Engineer II
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.
Typical tasks of the position include, but are not limited to
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.
The successful candidate will have a combination of knowledge, skills, and experience that would include the following
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... For full info follow application link.
It is the policy of TA Instruments to recruit, hire, and retain the best-qualified workforce while meeting the Company’s commitment to affirmative action and equal employment opportunity. TA Instruments does not discriminate against any qualified candidate for employment because of race, color, national origin, ancestry, religion, religious creed, age (40 or older), disability (reasonably accommodated by TA Instruments), medical condition, sex, marital status, sexual orientation, gender identity or expression, protected veteran status, pregnancy, genetic information or any other factor prohibited by law.