Description Provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with company standards and Medical Device Regulations
MAIN DUTIES & RESPONSIBILITIES: • Support the implementation of the standardized procedures, processes and systems for CAPA • Deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content • Assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination. • Maintain overall management and effectiveness of the CAPA system including the process and application for the site. • Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes. • Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA. • Provide CAPA compliance metrics and weekly management tracking report. • Implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management. • Facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems • Liaise with EU CAPA Manager in establishing and implementing company policies, procedures, and quality objectives. • Liaise with the EU CAPA Manager to align on system requirements to support the CAPA process • Identification and leadership of tactical continuous improvement opportunities • Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. Collaborate in the identification and implementation of corrective actions.
KEY COMPETENCIES REQUIRED:
• Demonstrated leadership ability • Excellent communication skills, to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry - Both verbal and written • Strong collaboration and influencing skills to partner effectively with other functions and across sites • System design and management skills - Organizational and Quality Systems • Expert knowledge of the US Quality System Regulations and ISO 13485 • Demonstrated track record of delivering best in class results in the Quality Systems area • Preparing presentations/slides in Power Point • Risk Management, NCR • Quality Management review (being first contact)
QUALIFICATIONS & EXPERIENCE
• Strong knowledge of quality and compliance for Medical Device Industry (GMPs). • Working knowledge of Quality System Regulations. • A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement • Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards • German: very good in spoken, good in written, English: fluent (spoken and written) is MUST •Technologie/Technology:MS office! (Power Point)
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