OverviewThis position is hands-on in a fast-paced environment which will interact with external suppliers and multiple internal functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, Purchasing, sister manufacturing sites and contract manufacturers) to resolve supplier quality issues. Primary responsibilities will be to analyze and measure supplier performance, implement corrective actions when needed, and draft quality agreements with suppliers to define the requirements between the supplier and Waters. The position is also responsible for performing quality audits on suppliers to ensure adherence to Waters expectations. Supplier Quality Engineers act as liaison for quality issues between our production areas, and our RDE, sustaining & test engineering departments and suppliers.Typical tasks of the position include, but are not limited to
Lead Supplier investigations to ensure root causes are determined and appropriate corrective actions are implemented to prevent repeat non-conformances. Ensure effectiveness checks are in place and robust.
Work as a driver to ensure suppliers meet timelines and requirements and not negatively impact Water's production schedule and overall business needs.
Execute effective Supplier Corrective Action and Preventive Action (CAPA) investigations.
Determine adequacy of part acceptance activities and make necessary improvements.
Review methods for inspection, testing, and evaluation of supplier provided material.
Confirm inspection criteria are appropriate.
Communicate effectively within the project teams as well as Sr. Leadership through project reviews and status reports including preparing reports and supplier quality metrics.
Conduct supplier audits to determine effectiveness of supplier process controls and effectiveness of their QMS (both qualification and ongoing maintenance audits).
Assist in the qualification and disqualification of suppliers in coordination with the Global Sourcing team, initiating improvement plans when necessary.
Support earlier development involvement with the product design team and advocate/influence DFMA best practices.
Monitor supplier processes and performance.
Provide guidance and ensure compliance with 21CFR820 and ISO13485:2003 Regulatory Requirements.
Drive continuous improvement of the supplier quality program
The successful candidate will have a combination of knowledge, skills, and experience that would include the following
Minimum of a Bachelors Degree, preferably within engineering related field.
Minimum 4 years of experience in Supplier Quality or related field.
Working Experience within a regulated industry (21 CFR 820, 21 CFR 211, ISO13485:2003, ISO9001:2008, AS9100, or TS16949) is preferred.
Working knowledge of ISO quality management systems13485 and 21 CFR Part 820.
Superior facilitation, and communication skills.
Strong leadership skills, self-directed and the ability to make independent decisions.
Project Management Skills.
Working knowledge of ISO Quality Management Systems.
Working knowledge of electrical and/or mechanical drawings (Geometric Dimensioning and Tolerancing-GD&T), and/or electrical and fluidic schematics.
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 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.
Waters Corporation's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.
Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.
TA Instruments, Inc.