Executive Director Quality Systems

vor 1 Monat


Frankfurt, Deutschland Weber & Company Vollzeit

Executive Director Quality Systems – EMEA

Frankfurt, Germany

Hybrid


Must have Medical Device Complaint Management & Post Market Surveillance experience.


Our Medical Device client with sales of $ 10 b has 70 + % market shares of the global Endoscopic market. It continues to innovate while emphasizing its commitment to improving the Quality of patient care. To stay ahead of fierce competition and surging demand while assuring FDA compliance, it needs to implement and harmonize its Complaint Management & Post Market Systems; drive performance and transform its culture in the EMEA.


As Executive Director Quality Systems – EMEA; reporting to a Global Vice President, you will specifically manage EMEA Complaint Operations; and be accountable for all Post Market Quality Systems (QMS), such as: Adverse Events, Field Actions, Market intelligence, MIR and Post Market Surveillance, to include direct FDA interaction. While in the trenches, for the future, you will architect and harmonize a world class QMS


You will also help lead the turnaround of significant FDA remediation platforms in collaboration with Senior Executive Management and your EMEA cross functional stakeholders.


Qualified Directors and Senior Managers must be operationally orientated; have a credible track record of implementing new processes and high activity Complaint Management Operations, preferably with complex mechanical and electromechanically devices. You must have the agility to be hands-on and to lead strategically, as a member of an outstanding global QA Management team.


You should have a track record of driving cultural change and business processes. Technically, you would need to be fluent with all Post Market Quality Management Systems; as well data analytics and trending. FDA remediation experience is a plus.


This is an exceptional position, that requires you to lead team, drive performance, handle day to operations, remediate FDA while building for the future. If you excel, your accomplishments will lead to rapid career advancement.


If you have what it takes, and are up for the challenge, please apply so that we may share more about this exceptional opportunity.



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