Operations Quality Engineer I

Waters Corporation is currently seeking a Quality Engineer to join our organization. This individual is responsible for process quality, data analysis, and for the planning and execution of process improvement projects supporting the Milling department of the Machine Shop within the Milford plant. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, supporting Statistical Process Control (SPC) initiatives, and driving projects related to product and process quality. This position is hands-on in a fast-paced environment which will interact with multiple functions (Process Engineering, R&D, and other operational departments) as well as additional supporting quality groups to resolve quality issues.

Lead investigations into product non-conformances, to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
• Work towards the improvement of product and process quality and overall customer satisfaction.
• Support the machining operations manufacturing process within the Milford plant by assisting in quality initiatives within the operations group.
• Lead improvement activities related to product and process quality in conjunction with our Process Engineering partners, including conducting process capability studies, qualifications, and gage R&R reports.
• Assist in the implementation of Statistical Process Control (SPC) throughout the Machine Shop where appropriate with the Quality Engineers, Process Engineering and Manufacturing.
• Collect and analyze data to identify trends, guiding quality initiatives, and provide feedback to our stakeholders.
• Learn and execute product inspections with a variety of inspection equipment; Use measuring instruments, engineering drawings, procedures, workmanship standards, etc. to perform inspection of parts and assemblies.
• Maintain inspection records and compile results of all inspections for internal feedback reporting system (SAP).
• Build inspection plans using SolidWorks Inspection and Prolink software to define features and inspection methods.
• Provide guidance and ensures compliance with ISO13485 & 9001, 21 CFR Part 820 and applicable good manufacturing practice regulations within the company.

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

Required Qualifications

• Minimum 1-2 years of experience in Quality Assurance or related field.
• Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T)
• 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.
• Ability to work independently across multiple organizations.
• Strong communication skills
• Machining and/or Manufacturing exposure
• Statistical Knowledge
• Minitab/SolidWorks/Prolink

Desired Qualifications

• Zeiss Calypso CMM Programming
• 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 various quality systems

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.