Director, Quality Systems 8/9/2016
JOB DESCRIPTIONAPPLY The Director of QualitySystems is responsible for directing and managing quality functions that sustain the infrastructure of the QualitySystem. S/he is responsible for ensuring the effective establishment and maintenance of qualitysystems in order to comply with the applicable regulations of all countries in which the company either manufactures or distributes products.
1. Establish strategic vision and direction for all corporate quality systems programs.
2. This associate is the Management Representative is the representative for all 3rd party audits.
3. Ensure continual evolution and advancement of standards and requirements for quality processes, including operational oversight and continuous improvement for proactive quality management.
4. Oversee quality system processes that span all company locations such as CAPA, Supplier Chain Quality, Systems software support, Product safety and sterility assurance.
5. Manage and develop QA staff and processes related to release of finished goods
6. Responsible for development of metrics, management of data and presentation of data to management in accordance with Management responsibility procedure.
* Requires a Bachelor's Degree in a technical/science/engineering field.
* A minimum of 15 years of experience in medical devices including 10+ years of extensive supervisory and team development experience.
* Regulatory or Quality certifications preferred.
* Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
* Ability to analyze and interpret all regulatory and quality guidelines needed
* Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards