Quality Assurance Director

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.