Waters Corporation is currently seeking a Quality Engineer to join our organization. In this role, the individual will lead the planning and execution of projects and activities for the facility to improve product and process quality, and analyzes quality data. This individual will also be responsible for improving and managing the non-conforming product system within the Milford manufacturing facility. Specifically, the individual will be responsible for the timely/accurate physical and transactional control of non-conforming product.
This individual is responsible for supporting the Waters Instrument Manufacturing Process within the Milford plant and for supporting the nonconforming product process within the Waters Manufacturing facility. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, leading Corrective Action and Preventive Action (CAPA) investigations, and driving improvement activities and projects related to product and process quality. Additional responsibilities include completion of nonconforming products records within Trackwise, active member of Material Review Board (MRB), and maintain physical and transactional control of discrepant material.
This position is hands-on in a fast-paced environment which will interact with multiple functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.
- Drive failure investigations to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
- Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system / GMP.
- Significant contributor to the non-conforming product system within the Waters Milford manufacturing facility. Administration of the non-conforming product system includes, but is not limited to:
- Act as chair for weekly MRB meetings and manage TrackWise quality records per the decisions made at the MRB meetings.
- Work with Research and Design, Manufacturing Engineering and Supplier Quality to disposition nonconforming product.
- Ensure proper inventory control for non-conforming product, which includes inventory moves processed through SAP and also physical management and storage of nonconforming product.
- Perform weekly metrics reports to determine current health of nonconforming process, as needed.
- Assist with TrackWise training, as needed.
- Lead a minimum of two continuous improvement projects each year to improve the processes related to product conformity and management of nonconforming product.
- Provide guidance and ensures compliance with ISO13485:2003, 21CFR820 and applicable good manufacturing practice regulations within the company.
- Bachelors Degree in Engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineer, etc), Business, Mathematics, Science, or technical field with emphasis on statistical skills. Advanced degree preferred.
- Demonstrated implementation of continuous improvement methodologies.
- Working knowledge of ISO Quality Management Systems.
- Exposure to process and/or software validation methods.
- Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T), along with electrical and fluidic schematics.
- Excellent communication and interpersonal skills.
- Ability to work independently across multiple organizations.
- Good report writing and reviewing skills.
- Experience in a electromechanical in the medical device manufacturing facility
- Operational Excellence/Six Sigma/Lean training or certifications
- Working knowledge of ISO quality management systems 13485 and 21 CFR Part 820
- Experience supporting the manufacture of complex electromechanical assemblies
- Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc)
- Experience using Sparta Trackwise
- 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 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.
Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We 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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