Head of Quality Assurance and Compliance

CooperSurgical, a leading fertility and women's healthcare company, is looking for a Director of Global Supplier Management to join our team. This role will be responsible for managing a team of supplier quality professionals and collaborating with cross-functional organization partners to ensure qualification and management of suppliers and service providers.

Key Responsibilities:

• Provide direct leadership to the Supplier Quality Assurance team, including prioritization of workload and shifting of resources to support the business.
• Develop vision and provide leadership for implementation of quality assurance responsibilities in the global management of direct, indirect, and purchased finished good suppliers.
• Track and report on supplier quality performance, including supplier complaints, corrective actions, and non-conformances.
• Participate in corporate-wide and department-specific meetings and functions, representing Supplier Quality Assurance.
• Collaborate with manufacturing/supplier teams to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality and reduce customer complaints.
• Provide input to the Global Quality Management strategic plan and budget.
• Develop and maintain a plan for the professional development, coaching, and performance management of all direct reports.
• Advise and participate in IT solutions for quality system improvements for Global Supplier Quality.

Requirements:

• Bachelor's Degree or equivalent in Engineering preferred.
• 10 years of experience in medical device/pharma industry, with experience in ISO 13485, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP required.
• 5 years of experience managing and developing staff (local or remote) required.
• Advanced level experience using MasterControl, Compliance Wire, and/or other LMS and eQMS software required.
• Strong knowledge of medical device supplier quality management and regulatory requirements required.