Job Title
CAPA Program Manager
Job Description
In this role, you have the opportunity to
Ensure that CAPA’s (Corrective Actions & Preventive Action) for our business unit Image Guided Therapy (IGT) Systems are processed appropriately. As the CAPA Program manager, you will manage R&D assigned CAPA’s in a quality and timely way. You are responsible for leading CAPA engineering activities like assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.
You are responsible for
* Leading and educating business partners in the generation, execution and completion of CAPAs
* Leading CAPA engineering activities like assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving
* Representing R&D in weekly CAPA Review Board to make decisions on CAPA phase transitions, defining ownership and opening of CAPA requests
* Maintaining a strong relationship with all other disciplines (e.g. Q&R, SQE, purchase, Marketing, OPS, legal) to get resources required for the R&D CAPA projects and defining CAPA ownership at 1st
* Maintaining a strong relationship with R&D management to report on CAPA status and ensure the right “Subject matter expert support” from R&D clusters
* Maintaining the CAPA profession and continuously improve efficiency and Quality of CAPA process and templates in cooperation with Q&R CAPA manager who is the CAPA process owner
* Manage backroom support for the CAPA’s in your program for Internal and external Quality and regulatory audits
* Driving the quality 1st culture in the organization, bringing the customer/patient impact stories to internal organization
You are a part of
The IGT R&D PMO group is tasked to successfully bring new product innovations to market and managing the life cycle of product in manufacturing and Installed Base. The team consists of 25+ people, all located in Best, of which 3 CAPA Program Managers and 20+ experienced Project Managers with their own focus area, managing cross-functional assignments varying from small activities to big projects.
To succeed in this role, you should have the following skills and experience
* You have a MSc degree in a relevant area of expertise like Physics, Electrical, Mechanical, Computer or Industrial Engineering
* You have at least 5-10 years’ experience as a Project Manager or CAPA manager/owner within medical device industry, automotive industry or aerospace
* You have strong Project Management skills (PMP)
* You are strong in stakeholder management and communication in a variety of levels in the organization
* You are a dynamic and enthusiastic team player who can drive actions. You are eager, ambitious and self-propelling, being able to provide solutions in a challenging & complex environment
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