Director, Quality Assurance, Manufacturing

About the role

The Director of Quality Assurance, Manufacturing leads the development, implementation and oversight of quality assurance policies, procedures and systems for complex medical device and pharmaceutical products. This senior position ensures compliance with global regulatory requirements and drives continuous improvement across the organization.

Key responsibilities

• Direct all phases of highly technical quality assurance audit activities for multiple entities.
• Oversee Quality Management Systems to ensure compliance with global MDSAP requirements.
• Plan, document and conduct QA audits of distribution centers, joint ventures, X‑Ray centers, private‑label manufacturers and non‑manufacturing suppliers.
• Manage supplier audits, monitor performance, and recommend process improvements.
• Research and apply applicable FDA, ISO and ASTM/ANSI standards to maintain U.S. and international regulatory compliance.
• Serve as FDA Official Correspondent, US Agent for foreign HS entities, Management Representative, and Person Responsible for Regulatory Compliance (PRRC) at manufacturing sites.
• Assist with due‑diligence, surveillance audits and act as subject‑matter expert for manufacturing partners.
• Assess existing policies and procedures, propose changes, and guide process and product transfer projects.
• Provide leadership, coaching and development opportunities to the QA team.

Required profile

• Outstanding management and leadership capabilities.
• Ability to provide direction and guidance to cross‑functional teams.
• Experience overseeing complex quality systems in regulated environments.

Required skills

• Knowledge of ISO 9001:2015 certification and maintenance.
• Knowledge of ISO 13485:2016 certification and maintenance.
• Familiarity with the European Medical Device Regulation (EU MDR 2017/745).
• Understanding of U.S. FDA Quality Management System regulations.
• Knowledge of MDSAP country‑specific regulatory requirements.
• Experience with ASTM/ANSI standards relevant to medical devices and pharmaceuticals.