Quality Systems Supervisor İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

Arvato Supply Chain Solutions is an innovative and international leading service provider in the field of e-commerce and supply chain management.

Partners come together with industry specialists in the fields of Telecommunication, Hightech & Entertainment, Automotive, Bank, Insurance, Healthcare, Consumer Products and Publisher.

More than 15,000 employees work together to provide practical and relevant solutions and services worldwide. Using the latest digital technology, Arvato develops, operates and optimizes complex global supply chains and e-commerce platforms, as the strategic growth partner for its customers. Arvato combines the know-how of its employees with the right technology and appropriate business processes to measurably increase the productivity and performance of its partners.

Arvato Supply Chain Solutions is a wholly owned subsidiary of Bertelsmann SE & Co. KGaA.

• Bachelor's Degree of Engineering (Preferably Industrial Engineering)
• Minimum 5 years of experience in similar position
• Experienced with establishment and maintenance of Quality Management Systems
• Having experience in Quality Assurance within a Medical Device Operation
• Knowledge of management systems and experienced with quality audit processes
• Having internal auditor or lead auditor certificates for ISO 9001:2015, ISO 14001:2015, ISO 45001, ISO 27001, ISO 10002, and ISO 13485 norms
• Good knowledge GxP guidelines (especially GDP)
• Having experience of proceed and lead of Validation / Qualification processes according to GxP guidelines
• Knowledge of personal data protection legislations (KVKK - GDPR)
• Able to work with different tools (SAP systems, Document and Quality Event Management tools such as QDMS, temperature control tool, etc.)
• Knowledge about Process Management and Ensemble tool
• Having advanced planning, management, organization and reporting capabilities
• Analytical, creative team leader, strong communication and persuasive
• Good knowledge of MS Office
• Knowledge of Six Sigma, FMEA, 5S, LEAN management is advance
• Good knowledge of English is essential (writing and speaking)
• Have an active driving license (B)
• No military obligation for male candidates
• Living/willing to live in Anatolian Side of İstanbul

JOB DESCRIPTION
In terms of Quality Management Systems;

• Leading Quality Improvement Projects relevant to the Quality Management System and Quality Assurance in respective processes and warehouses
• Managing Quality Team, and reports to Quality Systems Team Manager, Q&OHSE Manager
• Leading of “Process Management” under the process structure of the organization
• Managing documentation process among the Arvato SCS Process in line with Management Systems Policies
• Ensuring Risk Management coordination among processes
• Organizing / preparing of respective both internal and external Quality Trainings
• Leading the quality team to system developments such as QDMS, Ensemble tools
• Leading of quality team in the Calibration process
• Monitoring of PI/KPIs in the organization and report periodically to management.
• Ensure that internal and external audits schedules are prepared and adhered to as planned, carrying out of internal audits. Ensuring audit action items are closed within agreed timeframe
• Participation of Leadership Site Program (Warehouse audits) and supplier audits as an auditor
• Preparation of Management Review inputs and follow up outputs
• Review of CAPAs for all standards and monitor of effectiveness of Root Cause Analysis and Closures
• To make understandable of standardizations and compliance requirements for all processes and warehouses
• Follow up and provide compliance of updated standard and legislations in all Arvato SCS
• Update and maintenance of Business Continuity Plan within respective parties
  
  In terms of Healthcare Quality;
  

• Update and maintenance of Local Healthcare Quality documents in accordance with EU Healthcare Quality documentation
• Follow up Healthcare training status
• Managing CAPAs and Change Control
• Support the warehouse team and other departments with daily tasks and close relationship with them
• Quality trends preparation and participation of Monthly Online / Onsite EU QA Meetings
• According to the decision from the client, taking action with Operation Department on use of medical device products (blocking, release, recall, returns)
• Monitoring of Healthcare quality trends such as PEST, Temperature, Cleaning, Calibration, Maintenance