Supplier Quality Engineer II

Overview

This 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.

Responsibilities

• 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.

Qualifications

• Minimum of a Bachelors Degree, preferably within an 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.

Company Description

Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science. 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.