JOB DESCRIPTION:
Quality Operator
Support QA related process in the distribution center: incoming inspection, returns, quarantine shipments, ship holds, printing of IFU's, DHR reviews etc. in compliance with Abbott Quality system and ISO 13485.
Roles & Responsibilities
Against the background of the EMEAC QA system the following tasks will be performed according to SOPs and working instructions:
* Execute and follow-up on incoming and in process inspection (conducting visual inspections and rejecting non-compliant materials), returns, ship holds, quarantine shipments; document actions by completing reports and logs in the foreseen dbases
* Maintain Demo, SUBD, expired stock, Biohazard materials
* Ensure proper storage/labeling of all material requiring physical segregation: ship holds, quarantine, clinical trial products, products pending sterilization results, etc.
* Assist with internal audits
* Provide support in critical distribution activities including but not limited to labeling, packaging, shelf life extension, demo creation, scrap, service & repair, manufacturing activities (DHR review).
* Create high quality awareness in the EDC
* Updates job knowledge by participating in educational opportunities.
Education & Competencies
* High school level
* Minimum of 2 years of experience in a similar position
* Strong communication and documentation skills
* Computer and ERP literate (Microsoft Office and SAP)
* Preferably knowledge of ISO 9000, ISO 13485
* Fluent in Dutch, English. Any other European language is a plus
* Team player
* Stress resistant, working to tight deadlines
* Accurate and disciplined
* Analytical
* Independent
* Process driven
* Quality minded
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
Belgium : Bedrijvenzone Machelen - Cargo 831
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable