Supplier Quality Engineer I

Overview

Waters Corporation is currently seeking a Supplier Quality Engineer I to join our organization. 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. Responsibilities include supplier investigations into product non-conformances, reporting quality system metrics, supporting Statistical Process Control (SPC) initiatives, and driving projects related to product and process quality. 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

• Perform investigations into supplier issues to identify root causes and implement appropriate corrective actions to prevent recurrence of non-conformances. Ensure that effectiveness checks are robust and in place.
• Actively ensure that suppliers meet timelines and requirements to avoid negative impacts on Water's production schedule and overall business needs.
• Carry out effective Supplier Corrective Action and Preventive Action (CAPA) investigations.
• Assess the adequacy of part acceptance criteria and make necessary improvements.
• Verify that inspection criteria are appropriate and effective.
• Communicate effectively with project teams and senior leadership through project reviews and status reports, including the preparation of reports and supplier quality metrics.
• Conduct supplier audits to evaluate the effectiveness of supplier process controls and their Quality Management Systems (QMS), including both qualification and ongoing maintenance audits.
• Assist in the qualification and disqualification of suppliers in coordination with the Global Sourcing team, and initiate improvement plans as necessary.
• Support early development involvement with the product design team and advocate for best practices in Design for Manufacturing and Assembly (DFMA).
• Collaborate with other departments as needed to facilitate supplier change requests and supplier deviation requests.
• Provide guidance and ensure compliance with ISO13485, ISO 9001, 21 CFR Part 820, and applicable good manufacturing practice regulations within the company.

Qualifications

• Minimum 1-2 years of experience in Supplier Quality or related field.
• 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 systems 13485 and 21 CFR Part 820.
• Superior facilitation and communication skills.
• Capable of working independently and making informed decisions.
• Project Management Skills.
• Working knowledge of electrical and/or mechanical drawings (Geometric Dimensioning and Tolerancing-GD&T), and/or electrical and fluidic schematics.
• Desired Qualifications:
  • FDA 21 CFR 820 / ISO13485 / ISO 9001 / cGMP knowledge base
• Operational Excellence/Six Sigma/Lean training or certifications
  • Knowledge of various sampling plans
  • Knowledge of Inspection Methods

 

Qualified individuals should have a bachelor’s degree in engineering (Mechanical or Biomedical preferred), Mathematics (Emphasis on statistical skills), Business, Science, or related experience in a technical field directly relating to manufacturing.

 

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.

Key Words

GD&T Supplier Quality Quality Management Systems 21 CFR 820 21 CFR 211 ISO13485:2003 ISO9001:2008 Project Management