Overview:
The Quality Engineer will support the organization's Quality Department and its ongoing development, implementation, and maintenance of the Quality Management System (QMS) as well as monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Every day, you will assist in the planning and execution of projects and activities for the facility to improve product and process quality. As well as serve as a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction. This position reports to the Quality Manager.
Responsibilities:
Develop, implement, and maintain quality standards, tools, and methods for processing materials into finished products.
Knowledge of the industry and governmental regulations affecting product quality.
Responsible for coordination and documentation of calibration and preventive maintenance activity for the manufacturing facility and providing Quality support when needed.
Responsible for maintaining the approved supplier database and routinely engaging with suppliers
Lead internal audits to ensure company compliance to in-house and external specifications and Quality Standards (i.e., GLP, GMP, ISO).
Participate in CAPA and NCR process as an action owner and quality reviewer.
Collaborate with the internal laboratory groups to ensure quality standards are in place and improvements are implemented according to defined plans.
Evaluate data for completeness to applicable standards and procedures to provide plant clearance.
Conduct QMS Training of Waters personnel to support and maintain the QMS.
Qualifications:
* Bachelor's degree in science, engineering, or quality-related field
* 1 - 3 years of related quality experience or a combination of education and experience
* Experience working within a ISO registered Quality Management System
Skills Required
* Must have excellent written and verbal communication skills with a working knowledge of Microsoft Office applications (Word, Excel, PowerPoint)
* Takes initiative and demonstrates inquisitive approaches to solving moderately complex problems, identifying problems, generating alternatives, and recommending solutions
* Experience utilizing lean methodology and root cause analysis tools
* Excellent report writing and reviewing skills with an aptitude for technical writing
* Ability to work both independently and collaboratively as part of a cross-functional team
* Keen attention to detail and effective problem solving skills including root cause analysis
* Adaptable, able to manage multiple task/project and effectively prioritize based on the needs of the business
* Demonstrate enthusiasm to learn and share new methods and techniques within the area
* Take initiative and demonstrate inquisitive approaches to solving moderately complex problems (identifying the root cause, generating alternatives, and recommending solutions)
* Experience with Data Visualization and Analysis software (Power BI) preferred
* Initiative and aptitude to develop as SME/Process Lead in critical QA subprocesses
The general base pay for this position ranges from $64,000/year to $85,500/year. Pay is based on several factors including market location, job-related knowledge, skills, and experience.
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