CAPA - Facilitator

Description:

CAPA facilitator

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

You will support the Corrective and Preventive Action (CAPA) process from issue identification to closure and ensuring adequate execution of process and the quality of CAPA record content.

You are responsible for

• Supporting CAPA activities: assessing complex investigations and corrective actions, reviewing test and other complex performance data, leading complex root cause analysis and quality problem solving

• Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring

• Support CAPA Owner in all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines

• Support CAPA Owners in the presentation of CAPAs during audits and CAPA Review Board meetings

• Mentor cross functional teams with the implementation of appropriate root cause analysis techniques

• Mentor the analyze of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances

You are a part of

Our Quality & Regulatory organization, supporting the Diagnostic X-Ray Business.

To succeed in this role, you’ll need a customer-first attitude and the following

• B.Sc in Engineering or other relevant academic field as statistics, quality management, etc., advanced degrees – an advantage

• 5+ years’ experience in quality roles in medical device or other regulated industry

• Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971

• Good understanding of statistical methods, quality tools, problem solving tools and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) – an advantage

• Experience as team facilitator / team coach

• Work experience in complex organizations with Manufacturing, R&D and Engineering environments

• Strong communication and interpersonal skills, ability to coach teams in matrix environment cross-functional teams

• Strong technical writing skills

• Ability to resolve complex issues in creative ways and influence stakeholders accordingly

• Multi-tasking and decision-making capabilities

• Self-starter, motivated, action-oriented

• Experience working in global corporate environment

• Fluent English

Level of Experience

e. 8 - 10 Years