Job Details

Our On-Demand Talent Solutions team is excited to announce that we are hiring a Director of Quality Assurance. This role will support our client, a private medical device company focused on developing minimally invasive treatments for benign prostatic hyperplasia (BPH).

Summary: The Director of Quality Assurance will provide strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practices.

Responsibilities:

• Serves as Management Representative for the Quality System.
• Establishes, maintains, and routinely evaluates Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements while identifying opportunities to streamline processes.
• Leads and hosts FDA and regulatory agencies' quality system audits, ensuring audit readiness and compliance.
• Manages quality resources, including personnel, equipment, and budget, in alignment with departmental and corporate goals.
• Plans and manages internal audit activities and coordinates audit corrective actions (CAPAs).
• Leads and manages the quality group to ensure effective development, implementation, and continuous improvement of Quality System processes.

Qualifications:

• BS in a scientific or engineering discipline.
• Minimum of 10 years of Quality Assurance experience in the medical device industry.