Quality Assurance Director

Job Summary

Overseeing the quality oversight of design controls and risk management for combination product projects, the remote Director, Quality Assurance will manage compliance with regulatory standards and collaborate with cross-functional teams to ensure product safety and effectiveness.

Key responsibilities:

• Oversee the quality and compliance of combination products, ensuring they meet regulatory standards and company objectives
• Develop and implement quality strategies and processes for combination products in alignment with company goals
• Act as the QA contact for all quality-related inquiries and issues concerning device and combination products

Required qualifications:

• Bachelor's degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field; advanced degree preferred
• 10+ years of experience in quality oversight of drug product device development with a proven track record of successful product launches
• Experience in quality oversight of design controls and combination products is required
• In-depth knowledge of global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and EU MDR
• Familiarity with combination product lifecycle management from initial design phase to commercialization