SAP S/4HANA Data Design Expert - OTC

Global Enterprise Partners is currently looking for an SAP S/4HANA Data Design Expert - OTC to join an exciting project for a global client.

What we are looking for:

• Min 2 years of experience in Quality Management Systems
• Good command of English is compulsory
• Knowledge of design control, risk management, root cause investigation methods, process validation, statistical process control (SPC), protocol/report preparation.
• Knowledge of ISO 13485, European Medical Device Regulation and FDA 21 CFR 820 requirements, understanding the medical device regulatory environment and requirements
• Familiar with QMS processes like Technical File preparation, CAPA, Complaint management, document control, internal audit etc.
• Good knowledge of MS Office applications is required and SAP is an asset
• Internal auditor certification preferred
• High level of attention to details and accuracy
• Be self-motivated, self-starter, be able to meet deadlines, be a good team player, be able to assist and support others
• Ability to travel as required

What you'll be doing:

Quality Assurance:

• Non-Conforming Product Management with using QDMS
• Product Release
• Control and approval of laboratory routine test results
• HHE,FSCA, Hold processes
• Customer Complaints Reporting Process

Quality Assurance -QMS:

• Management of Corrective and Preventive Actions with usign TrackWise
• Internal audits with using QDMS
• Management of Document Control Process with using QDMS
• External audits
• QMS statistical analyzes
• KPIs/Quality Objectives
• Quality Management System Plans
• Quality Management System trainings with using LMS

Design Quality:

• Computerized systems validation
• Control and approval of validation studies (Process, test method etc.)
• Control and approval of Receiving Inspection plans
• Control and approval of label designs/layout
• Control and approval of Technical File Content

Contract details for the role:

• Duration: 12 months
• Hybrid (Portugal)
• Agreement: (40 hours per week)

Interested? If you, or somebody else you know could be interested in the above position please apply directly with an updated CV or call me directly.