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.
