Director, Quality Assurance

Responsibilities :

• Ensure compliant conduct per QSR, ISO, and corporate requirements as the designated management representative for the site.
• Support the realization of new products through new product development, third party manufacturers, and / or mergers and acquisitions, including oversight of Design Controls.
• Develop, communicate and build consensus for quality goals, objectives and programs that support business unit and company goals; identify and make recommendations for strategic direction within the site and / or business unit.
• Prepare and maintain the departmental budget; effectively make decisions to utilize resources maintaining department budget while meeting department and business unit goals.
• Develop site and / or organizational policies and authorizes their implementation.
• Oversee the development, maintenance, and improvement of the Quality Management System, including promoting QMS harmonization across sites and identifying opportunities for improvement within the QMS and related systems.
• Liaise with manufacturing as it relates to Quality, including internal audits, incoming materials and product distribution.
• Partner with IT and QARA leadership to maintain and enhance the learning management system and other QMS systems as the administrator for the site.
• Ensure appropriate QSR and ISO audits are performed for critical suppliers and service organizations; ensure proper quality agreements are maintained per Company procedures.
• Attend QA Global One meetings to discuss global initiatives, challenges, etc.
• Support cross-company projects and / or new product development as the site Quality contact between SMD (or other Subsidiary Companies).
• Provide QA support and direction for contract manufactured products.
• May lead Corrective and Preventative Action (CAPA) investigations and resolve potential product quality issues as they relate to compliance or continuous improvement.
• Demonstrate commitment to the development, implementation and effectiveness of Company’s Quality Management System per ISO, FDA, and other regulatory agencies.
• Understand and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Responsible for exhibiting professional behavior with both internal / external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Carry out duties in compliance with established business policies.

Background Requirements :

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