Senior CAPA Consultant

For our customer in Solothurn we are looking for a project ASAP for a Senior CAPA Consultant

Job purpose:

- 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 and Responsbilities:

- 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
- Identify opportunities for procedural harmonization and integration.
- Identify and establish best practices, ensuring best company practices are utilized throughout Global Orthopaedics
- 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.
- Ensure effective and timely completion of all 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
- Excellent presentation, facilitation and training skills
- Strong collaboration and influencing skills to partner effectively with other functions and across sites
- Team building and development capabilities
- 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
- Fluent in German and in English - able to interact, generate processes and procedures and educate and train

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.
- Demonstrated knowledge of business impact of compliance issues and risk management.
- Proven ability to build partnerships both internally and externally.
- THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES

Are you interested in this position? Then we are looking forward to receive your application.