Job Title

Job Description

• Managing the Product Hold process for IGT-Systems (Fixed System) for products manufactured in Best (Netherlands); and support Suzhou (China) and Pune (India) as required (e.g. back up)
• Organizing the collection of all information needed for the Hold determination and initiation; like problem statement, risk assessment and Unit Affected List (UAL)
• Facilitating the Hold initiation meeting and subsequent communication to the Market Regions
• Creation (and/or supporting the creation) of documentation required by the Hold process; like e.g. Hold initiation form, Communication form, UAL and Hold closure forms
• Collaborating with key stakeholders required for the execution of the Hold process such as Hold coordinator peers in the Market Regions, Factory and Service organizations to effectively manage the timely segregation of products, and execution of disposition activities to ensure that non-conforming products are not handed over to customers around the globe.
• Support the Identification and maintenance of appropriate metrics on the efficacy and efficiency of the Hold activities and monitoring and reporting on those metrics
• Being the Hold process expert for IGT-Systems in Best

• Bachelor’s Degree, preferably in biomedical engineering, science, healthcare, or medical profession
• 5 years’ experience in Quality in Medical Device and/or other regulated industry preferably in Risk Management, Design Quality, Correction and Removal/Recalls, Complaint Handling or PMS
• Focus on detail
• Good analytical skills and process improvement mindset
• Teamwork
• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers)
• Hands-on with High level of initiative, engagement, self-motivation and flexibility
• Able to work in a changing environment and be a driver of change
• Product Knowledge is preferred