Quality Assurance Director in Woodbury - CV-Library

TEC Partners is pleased to have partnered with a leader of innovation, development, and manufacturing solutions to the pharmaceutical and medical device industries. As one of the largest suppliers in the Life Science arena on a global scale, my client works closely with customers to provide highly engineered products that help millions live healthier lives!

Quality Assurance Director:

Provide direction and leadership to the Quality teams including people management.
Maintain and improve quality systems to support the Strategic Plan for new business opportunities
Ensure compliance with medical device and pharmaceutical regulations and quality system requirements.
Work with the Commercial team to represent Quality System with customers and potential customers
Work with management on risk assessment and regulatory compliance
Drive Continuous improvement activities
Provide expertise for the continuous improvement of the quality system as it pertains to combination products

Quality Assurance Director Requirements:

B.S. degree in quality, business, or engineering field
Ten (10) years or more experience in a quality role within medical devices
Five (5) years or more experience in a management role
Knowledge of FDA and international regulations and ISO standards related to medical device design and manufacturing (e.g., MDR, 21 CFR 11, 820, 211, and ISO 13485, 14971)
Direct experience with audits and pre-approval inspections by regulatory authorities

If you are passionate about quality, compliance, and driving excellence in the medical device sector, please apply with an up to date CV