Quality Engineer I
Req. #
20979
Job Family
QA - Quality Assurance & Control
Location
US-MA-Milford
Overview
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 manufacturing and assembly of product 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, NPI and other operational departments) as well as additional supporting quality groups to resolve quality issues.
Responsibilities- 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.
Qualifications
Education:
- 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:
- 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
- Smartsheet/Power Bi
- 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), 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 benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and 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.
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