پست شده در: ارتباطات تلفنی در آیداهو | آخرین بروزرسانی: |
Job Description
The Quality Assurance Engineer, in conjunction with the Quality Assurance (QA) team, will ensure that the quality management system (QMS) of LGC’s Middleton site conforms to the ISO 13485 standard. This role will ensure that all processes, procedures, and practices remain current and compliant with the expected standard. As a business partner to other critical functions, such as Manufacturing, this individual is expected to effectively build and maintain cross-functional working relationships, analyze data to develop appropriate actions, and support a culture of collaboration and accountability.
In partnership with process owners and stakeholders, implement, maintain, and improve procedures for the quality management processes under designated area of responsibility.
Work and communicate effectively across departments to implement QMS improvements and to maintain its effectiveness
Serve as the process owner for one or more of the following QMS processes or programs: corrective action and preventive action (CAPA); internal QMS audit; support of supplier qualification/monitoring with Group Procurement; nonconforming material; equipment calibration
Participate in the following QMS activities as assigned: review and release of manufacturing and QC testing batch records; investigate and document root causes of nonconformances
In conjunction with CAPA owners, facilitate CAPA’s through verification of effectiveness
Assist in the determination and delivery of quality system training requirements
Generate, review, and approve production deviations, complaint investigations, and nonconformance reports for non-conforming materials
Review and approve material and product specifications and the acceptance criteria for equipment qualifications and process validations
Lead by example through continuous learning and diligently following the requirements of the site’s QMS