My client is a global growing innovative medical device company currently growing their QA department and looking for a Senior QA manager to join one of their offices based in south of Netherlands.
You will be responsible for implementing continuous improvements and provides vision and leadership for strategic projects and maintaining the Quality System, including Quality Assurance mandates. Identifies and assures optimal product and process quality within the quality system and regulatory requirements. Understands and applies quality principles to support an effective overall quality system, including initiatives in conjunction with the Director of Quality Assurance.
•Manages all personnel, activities, initiatives and site specific programs in the achievement of quality organizational goals, as well as Corporate initiatives related to the Quality System;
•Interfaces with other members of Management with respect to regulatory compliance, as well as implementing continuous improvements initiatives;
•Sets policy and procedures for the Quality processes at the European DC;
•Responsible for interacting with internal sites and external customers on Quality related issues;
•Provides vision and leadership for strategic projects;
•Works collaboratively across functions, regions and business units to deliver results;
•Contributes to organizational efficiencies through recommendations regarding new corporate standards and procedures;
•Acts as Subject Matter Expert in internal and external audits.
•Quality Compliance: Ensures the Quality System is substantially compliant to GMP/QSR practices and standards as defined by the FDA, ISO and regulatory bodies in close coordination with the Quality Systems Manager;
•Quality Metrics & Communications: Develops and generates quality metrics reporting/tools as well as process improvements.
•B.S. Degree with minimum of 9-10 years’ experience in quality for medical devices and/or pharmaceuticals.
•Demonstrated leadership & people management experience within a functional management role.
•Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
•Excellent communication skills with the ability to influence others.
•Strong command of the English language (verbal & written).
For more information please contact Noemie Oliva at email@example.com