Beschreibung
Subject Matter Expert - EU Management Legacy Review - Solothurn, Switzerland
Key Competencies Required:
Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
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
The ability to independently analyze data and identify trends to improve overall quality systems compliance, effectiveness, and efficiency
Able to review CAPA & sub-system data and documents & interact with Quality Management & site process SMEs
Qualifications & Experience
Essential:
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
Perform Management Review Legacy Reviews per protocol to ensure adequate review of quality and reliability data associated with the Quality Management System.
Main Duties & Responsibilities:
Perform Management Reviews per protocol per schedule. This includes gathering data, performing trending and analysis, generating presentation slide deck with appropriate summary conclusions, organizing the appropriate management for the review, and assisting in the presentation of the slide deck.
Demonstrate knowledge of, and ability to, apply appropriate statistical techniques in support of trending and analysis.
Engage with local Quality Management and site process SMEs to ensure adequate recording, evaluating, and reporting of quality and reliability data associated with the Quality Management System for Quality System Management Review.
Ensure proper data transformation into thorough information and metrics.
Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
Provide support for documentation of review completion including action plans.