Manufacturing Operations QA Director

Manufacturing Operations QA Director

Requirements

• Bachelor’s degree required.
• Minimum of 10 years of relevant Manufacturing Quality / Engineering experience with 7+ years of managerial experience, or an advanced degree with a minimum of 8 years of relevant Manufacturing Quality / Engineering experience with 7+ years of managerial experience.

Responsibilities

• Lead the manufacturing site towards excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first.
• Develop and implement comprehensive training programs to enhance team skills and capabilities.
• Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices.
• Collaborate cross-functionally with colleagues in Global Operations & Supply Chain, Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.
• Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards.
• Lead audit and inspection preparation, resolving findings, and liaising with auditing groups and inspectors.
• Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues and institutionalizing organizational learning.

Preferred Qualifications

• Experience in Medical, Pharmaceutical or highly regulated product industry.
• DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.
• Demonstrated experience leading Kaizen Events and multiple Quality-related functions.
• Experience with vascular / neurovascular products.
• Strong leadership, change management, and transformation skills.
• Excellent communication, interpersonal, and talent management skills.