Waters Operations Quality Engineer in Golden, Colorado
For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.
Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
ERA, A Waters Company is the leading Proficiency Standards Company in the United States. In this role, the Operation 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.
Assist in the planning and execution of projects and activities for the facility to improve product and process quality
Serve as a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction
This position reports into the site Quality Manager
The position is located in Golden, Colorado, relocation for this position will not be provided.
Job Duties and Responsibilities:
Duties and Responsibilities include (but are not restricted to) the following:
Develop, implement, and maintain quality standards, tools, and methods for processing materials into finished products. Knowledgeable of industry and governmental regulations affecting product quality
Responsible for the coordination and documentation of calibration and preventative maintenance activities for manufacturing facility and providing Quality support where needed
Assist with writing and executing equipment, instrument and process validations, test method validations, test protocols and reports (IQ, OQ, PQ)
Responsible for ensuring that the Control of Nonconforming Product is conducted as required per ISO Quality Standards and Waters QMS
Drive failure investigations to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances
Responsible for reviewing documentation (records, procedures, work instructions, forms etc.) to ensure accuracy, completeness and compliance with the process, and requirements of the QMS
Assist with establishing quality-related activities associated with raw material acquisition, receiving and in-process inspection
Participate in internal audits to ensure company compliance to in-house and external specifications and Quality Standards (i.e., GLP, GMP, ISO)
Participate in the CAPA process as an as action owner and quality reviewer
Collaborate with internal laboratory groups to ensure quality standard 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
Bachelor’s degree in science, engineering or quality-related field and at least 3 years of related quality experience or a combination of education and experience
Experience working within an ISO registered Quality Management System. Knowledge of ISO 17025/Guide 34 preferred
Experience working in a either a laboratory or manufacturing environment
Must have excellent written and verbal communication skills with a working knowledge of Microsoft Office applications (Word, Excel, PowerPoint)
Good report writing and reviewing skills
Ability to work both independently and collaboratively as part of a cross-functional team
Keen attention to detail and effective problem solving skills
Adaptable, able to manage multiple tasks/project and effectively prioritize based on the needs of the business
Ability to apply theoretical and practical knowledge to commonly encountered quality problems
Demonstrates enthusiasm to learn and share new methods and techniques within area
Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems (identifying root cause, generating alternatives and recommending solutions)
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as needed to meet the ongoing need of the organization.
External Company URL: www.waters.com