Capa Program Manager
3 maanden geleden
**Job Title**: CAPA Program Manager
**In this role, you have the opportunity to**
Ensure that CAPA’s (Corrective Actions & Preventive Action) in 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. This is done through education and partnering with CAPA owners and relevant stakeholders across all business functions. Are you up for a challenge to be end-to-end responsible to solve your own program list of CAPA’s? Would you like to see the results from your efforts directly in the business? Then please read further and apply
**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.
- Driving progress of R&D CAPAs in line with IGT systems quality targets.
- Maintaining a strong relationship with CAPA feeder systems to ensure that initial analysis and risk assessments are done timely.
- Ensuring that CAPAs are opened at the right moment with valid CAPA triggers.
- 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 en ensure the right “Subject matter expert support” from R&D clusters.
- Reporting on progress of R&D CAPA’s to IGT systems management.
- 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.
- Support Internal and external Quality and regulatory audits by presenting the CAPA records on request.
- Manage backroom support for the CAPA’s in your program for Internal and external Quality and regulatory audits.
- Handshake, program and monitor CAPA implementation tasks in the Business Program Team and with Process Owners.
- 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
- You have strong Project Management skills (PMP)
- You are strong in stakeholder management and communication in a variety and on different 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
**About Philips**
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
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