CAPA facilitator
3 maanden geleden
CAPA Facilitator
Start Date:ASAP
Duration: 1 year
Location: Philips Best
Philips, a global leader in health technology, is committed to improving billions of lives worldwide and making the world healthier and more sustainable through innovation. We are driven by the vision of a better tomorrow. At Philips, we are a diverse team of 80,000 individuals united by our sense of purpose and determination to meet our customers' needs. This inspiration drives us to create meaningful solutions that make a real difference when it matters most.
As the world and our customers' needs evolve rapidly, we recognize the need to do more. That's why we need you to help us address increasingly complex challenges in health and well-being.
In This Role, You Have the Opportunity to Make Life Better:
In this position, you will support the Corrective and Preventive Action (CAPA) process from issue identification to closure, ensuring proper execution and quality of CAPA record content. Your efforts will contribute to creating a better and fairer future for all.
Responsibilities:
- Support CAPA activities by assessing complex investigations and corrective actions.
- Review test and other performance data.
- Lead root cause analysis and quality problem-solving efforts.
- Facilitate product and process CAPA investigations from issue identification through solution implementation and effectiveness monitoring.
- Assist CAPA Owners in all aspects of CAPA activities, including resource coordination, team meetings, and project timeline adherence.
- Support CAPA Owners during audits and CAPA Review Board meetings.
- Mentor cross-functional teams in root cause analysis techniques.
- Analyze quality monitoring data and apply statistical methods to identify causes of non-conformances.
You Will Be a Part of Our Quality & Regulatory Organization, Supporting the Magnetic Resonance Imaging Business.
To Succeed in This Role, You’ll Need:
- A B.Sc in Engineering or a relevant field (e.g., statistics, quality management); advanced degrees are an advantage.
- Experience in quality roles within the medical device or other regulated industries.
- Working knowledge of global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
- Proficiency in statistical methods, quality tools, and problem-solving methodologies (e.g., 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) is an advantage.
- Experience as a team facilitator or coach.
- Experience working in complex organizations with Manufacturing, R&D, and Engineering environments.
- Strong communication and interpersonal skills with the ability to coach cross-functional teams in a matrix environment.
- Strong technical writing skills.
- Ability to resolve complex issues creatively and influence stakeholders.
- Multi-tasking and decision-making capabilities.
- Self-starter, motivated, and action-oriented.
- Experience working in a global corporate environment.
- Fluent in English.
If you have any questions please get in touch with me at ritika.agarwala@yacht.nl