Vice President, Quality Operations – CSS

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION 

The VP, Quality Operations is a key member of the Quality Leadership Team (QLT) and the Codman Specialty Surgical (CSS) Divisional Leadership Team with primary responsibility to ensure the delivery of high-quality products and services to our customers.  This position has direct responsibility for quality across our CSS division with nine manufacturing sites and a network of stakeholders focusing on compliance, quality, safety, and efficiency. This individual will build strong partnerships with all internal functions, ensuring demand is met as well as cGMP compliance and will work internally across the organization to provide the passion, vision and results-oriented leadership required to build a world-class quality organization.  This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows: 

• Create and implement best practice quality vision, strategy, policies, processes, and procedures to aid and improve business performance.  Lead and drive operational efficiencies and compliance across all Integra CSS manufacturing sites.  Provide overall quality management oversight and leadership for the CSS division such as monthly management reviews, site compliance, non-conformances and CAPA, product holds, audits, product release and inspection, complaint investigation, facilities and equipment controls, and more.  Partner with the Quality Leadership Team to ensure the delivery of high-quality products and services to our customers. 

• Ensure that Quality meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.  Provide strategic direction and communication of quality performance across the CSS division, creating a clear vision and integration with overall business objectives.  Develop and monitor key performance indicators (KPIs) to assess the performance of product quality and the quality management system.  Highlighting trends, risks, and opportunities for improvement. 

• Proactively drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically.  Foster a culture of quality and continuous improvement within the organization. Promote the use of lean and Six Sigma methodologies to enhance quality and operational efficiency. Stay abreast of industry trends and advancements in quality management practices.  Monitor and partner with the Quality Leadership Team to ensure that Integra’s Quality Systems continue to meet emerging industry trends.