The Executive Director of Quality Systems is responsible for overseeing and managing the quality control processes and procedures within an organization - Universal, United States - Quantum Innovations

Quantum Innovations
Quantum Innovations
Verified Company
Universal, United States

2 weeks ago

Meredith Sinclair

Posted by:

Meredith Sinclair

beBee Recruiter
Description

Executive Director Quality Systems – EMEA

Location: Frankfurt, Germany

Employment Type: Hybrid

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

Our client, a leading medical device company with sales of $10 billion, holds over 70% of the global market share in the Endoscopic market. They are committed to continuous innovation and improving patient care. To stay ahead of competition and meet FDA compliance, they are seeking an Executive Director to implement and harmonize their Complaint Management & Post Market Systems in the EMEA region.

As the Executive Director Quality Systems – EMEA, you will report to the Global Vice President and be responsible for managing Complaint Operations in the EMEA region. You will also be accountable for all Post Market Quality Systems, including Adverse Events, Field Actions, Market Intelligence, MIR, and Post Market Surveillance, with direct interaction with the FDA. In addition, you will be responsible for architecting and harmonizing a world-class QMS for the future.

You will also play a key role in leading the turnaround of significant FDA remediation projects, working closely with Senior Executive Management and cross-functional teams in the EMEA region.

The ideal candidate will have a strong operational background and a proven track record of implementing new