Philips
CAPA Specialist/ Quality & Regulatory Specialist
Location: Best
Hours/week: 40
Budget range: €3.800 - 5.200 per month
As a CAPA Specialist, you will play a vital role in improving lives and ensuring the highest standards of quality in the healthcare industry. Your main responsibility will be to support the Corrective and Preventive Action (CAPA) process, from identifying issues to their successful resolution and ensuring the quality of CAPA record content.
Key Responsibilities:
Assist in CAPA activities, including assessing complex investigations and corrective actions, reviewing performance data, and leading root cause analysis and quality problem-solving.
Facilitate CAPA investigations from issue identification to solution implementation and effectiveness monitoring.
Support CAPA Owners in coordinating cross-functional resources, scheduling CAPA team meetings, and meeting project timelines.
Assist in presenting CAPAs during audits and CAPA Review Board meetings.
Mentor cross-functional teams in implementing root cause analysis techniques.
Analyze quality monitoring data using statistical techniques to identify non-conformance causes.
To Excel in this Role, You Will Need:
5+ years of experience in quality roles in medical devices or other regulated industries.
Working knowledge of global regulations, requirements, and standards (e.g., 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971).
Understanding of 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.
Strong technical writing skills.
Ability to creatively resolve complex issues and influence stakeholders effectively.
If you're ready to be a part of a purpose-driven team, committed to creating a better world, and have the qualifications and mindset we're looking for, we encourage you to apply before October 21, If you have any questions do reach out at Pallavi.mahadik_1@philips.com.