The Quality Engineer is responsible for supporting activities related to the implementation, maintenance and continuous improvement of Aldevron's electronic quality management system (eQMS) (i.e. AssurX). This role supports the eQMS user needs and requests. This role provides technical assistance for planning, organizing, designing and implementation of the modules within the eQMS for release for use within a regulated environment. This role assists with the administration of Quality records within electronic systems such as AssurX and NetSuite.
Essential Duties and Responsibilities:
- Support quality system programs, processes and facilities by ensuring compliance with internal, regulatory, and client requirements in the manufacture of products.
- Support qualification and validation activities through review, approval, and/or execution of qualification protocols, reports, and associated records.
- Support the change control process through identification, implementation, verification, and closure of required changes in collaboration with the CCR Board.
- Support the CAPA system by ensuring events are adequately investigated, documented and communicated; appropriate CAPAs are identified and implemented; and, all records are closed on time.
- Perform effectiveness verifications and trending assessments.
- Compile, distribute and report management review data in support of Quality Systems Management Review.
- Perform internal audits, manage the internal audit schedule, and oversee identified corrective and preventive action requirements.
- Assist with supplier qualifications, perform supplier evaluations (e.g. on-site audits), manage the supplier audit schedule, and oversee identified corrective action requirements.
- Modify and customize the eQMS to improve functionality and efficiency.
- Support activities related to the development of new system process workflow customization and capability alternatives within the eQMS.
- Support users of eQMS in troubleshooting and password resets; conduct new hire/user access training for the eQMS.
- Support continuous improvement projects addressing process efficiency, costs and performance.
- Assist with inspection readiness activities including audit/SME preparation.
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.