Director of Quality Assurance

Job Description
Summary
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Oppertunity to work on Dynamic Product in Growing Medical Device Company
Have entire oversight of Quality Department reporting into the Vice President

About Our Client

My client is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The company's FDA-approved product has successfully treated more than 10,000 patients in the United States, Europe and Japan

Job Description

The key responsibilities of the Quality Director are

Direct activities for the quality assurance group. Manage quality function to support sales, operations, and product development.
Active participant and responsibility for the hosting of external and internal audits including coordination with auditing groups(s) and internal stakeholders throughout the audit process.
Demonstrated experience supporting manufacturing, sustaining and R&D engineering projects through all phases of the product life cycle.
Overseeing the preparation of and reviewing/approving validation protocols and reports, risk analyses, and standard operating procedures.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The succesful Director of Quality will have

Ability to lead by example to oversee and mentor direct reports in the quality assurance department.
Strong and thorough knowledge of quality engineering tools and concepts.
Quality Management Systems development, maintenance, and auditing per ISO13485/EU MDR/FDA QSR.
Quality planning, data collection, and charting and statistical methods, including sampling.