Quality Assurance Director

Join Our Innovative On-Demand Talent Solutions Team! We are thrilled to announce an exciting opportunity for a Quality Assurance Director to support our client, a pioneering private medical device company specializing in minimally invasive treatments for benign prostatic hyperplasia (BPH).

Role Overview: The Quality Assurance Director will play a critical role in providing strategic leadership and management of quality assurance functions. This position ensures compliance with all relevant national and international regulations, standards, and best practices.

Key Responsibilities:

• Act as the Management Representative for the Quality System.
• Establish, maintain, and regularly evaluate Quality System policies and procedures to guarantee compliance with FDA QSR, ISO 13485, and EU MDD requirements while actively seeking opportunities to optimize processes.
• Lead and manage quality system audits conducted by the FDA and regulatory agencies, ensuring audit preparedness and adherence to compliance standards.
• Oversee quality resources, including personnel, equipment, and budget, aligning them with both departmental and corporate objectives.
• Plan and coordinate internal audit activities and manage audit corrective actions (CAPAs).
• Guide and mentor the quality group to ensure the effective development, implementation, and continuous enhancement of Quality System processes.

Qualifications:

• Bachelor's degree in a scientific or engineering discipline.
• At least 10 years of experience in Quality Assurance within the medical device industry.