Overview:
Waters Corporation is currently seeking an Operations Quality Engineer II to join our organization. This individual is responsible for process quality, data analysis, and for the planning and execution of process improvement projects supporting operations within the Milford plant and the Global Distribution Center (GDC). Responsibilities include leading investigations into product and process 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 with 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.
Lead investigations into warehouse or shipping non-conformances including damaged goods, to ensure root causes are found and appropriate corrective actions are implemented to prevent recurrence.
Work towards the improvement of product and process quality and overall customer satisfaction.
Support operations within the Milford plant and the GDC by assisting in quality initiatives within operations.
Lead improvement activities in Milford and in the GDC 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 Milford plant and GDC with appropriate 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 as required using 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).
Provide guidance and ensures compliance with ISO13485 & 9001, 21 CFR Part 820 and applicable good manufacturing practice regulations within the company.
Qualifications:
Qualified individuals should have a bachelor's degree in engineering (Mechanical or Biomedical preferred) and a minimum of 4 years experience in a technical field directly relating to manufacturing and/or warehousing.
Minimum 2 years of experience in Quality Assurance or related field applied to manufacturing or warehouse controls.
Working knowledge of Quality Management Systems to drive process compliance and improvement.
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
. Warehouse operations or quality experience
Statistical Knowledge
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