Abbott Senior Quality System Specialist in Machelen, Belgium
We are recruiting a Senior Quality System Specialist for our European Distribution Center (EDC) in Machelen.
The purpose of the role is to assist the Quality and prevention manager in the implementation and maintenance of the quality system in the distribution center.
More specifically, the Senior Quality System Specialist will:
Monitor compliance of the EDC procedures and instructions to external and internal quality and regulatory requirements, ensure SOPs and instructions are aligned and changes are processed through Change request and document control process.
Perform internal audits and assist in supplier assessments according to the internal audit program.
Support preparation to external audits & internal audits, assist Quality & prevention manager during external & internal audits.
Support and monitor metrics for certain quality related processes
Take ownership in specific QMS continuous improvement projects as assigned and agreed with line manager.
Support quality control processes within EMEA QMS for EDC: CAPA, Change Control, Risk Management, Deviation handling, Supplier assessment and evaluation, etc.
Monitor and follow up on timely submission and completion of corrective actions to Audit observations in EDC.
Support in development, follow-up and implementation of Quality Plans.
Support in validation activities and control of validation documents
Closely monitor critical distribution activities including but not limited to labeling, packaging, shelf life extensions, demo creation, scrap, service & repair and manufacturing activities
Support execution of clinical trials activities including but not limited to ensure products are properly stored, ensure returned products are processed properly, provide requested reports on traceability, follow up on dispositioning of products when trial is completed.
Support execution of stop ship and recall activities while interacting with EMEA RA/QA and manufacturing.
Communicate recommendations to quality & warehouse management
Create high quality awareness in the EDC
Other tasks assigned.
Education & Competencies:
University degree, graduated science, or equivalent work experience
Experience with Quality Systems
Experience in internal audits is a plus
Knowledge of the MDD, AIMDD and ISO 13485 is required
Working proficiency in English language
Extensive MS Office skills, computer literacy
Ability to respect confidential nature of information
Focused on maintenance of effectiveness of processes
Good communication skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com