Position Summary

The Vice President of Quality is responsible for providing Quality leadership for the consumables function here at STERIS. The VP of Quality will be responsible for ensuring that the processes needed for the Quality Management System (QMS) are established, implemented, and maintained in accordance with the applicable Quality System Regulation and other standards for their respective Business Units or functional area.

Day in the Life:

• Leads strategies to enhance and ensure implementation of STERIS Quality System.
• Formulates risk reduction and mitigation tactics, where necessary.
• Leads manufacturing, processing, or service quality staff within their respective Business Unit or functional area in the execution and continuous improvement of the STERIS Quality System. Operates collaboratively with a focus on the following objectives:
  • Ensure compliance to appropriate ISO, FDA, and other applicable regulatory requirements.
  • Drives and implements strategies and objectives to continuously improve quality performance.
  • Establishes clear and consistent quality measurement systems in order to monitor and drive results.
  • Leads supplier quality improvement strategies and the development of supplier improvement programs.
  • Lead the continuous improvement and standardization of quality system procedures and effectiveness monitoring.
  • Establish world class levels of product reliability by fully integrating design for reliability tools and techniques within the quality system.
• Directs staff on planning sequential and concurrent quality activities. Establishes planning and monitoring tools and techniques.
• Provides Quality viewpoints, influence, and opinions to key business leaders in planning and specifying existing and future products.
• Take ownership and delivers on the resolution of Quality issues, implementation of projects and development activities within their respective Business Unit or functional area.

Day in the Life con't:

• Manages and provides direction to a team of quality professionals with the responsibility for hiring, performance management, appropriate staffing, and deployment of resources.
  • Identify, retain, and develop top talent, establishing a team of highly motivated, high-performing, and engaged Associates.
  • Develop, lead, and mentor team members through active coaching, development plan implementation, accountability, and demonstrating professional excellence.
  • Create a Customer-centric culture of Quality, Safety, Accountability, and Continuous Improvement.
• Lead in a matrixed environment and in close partnership with key team members across various functions to ensure objectives are aligned and achieved.
• Works closely with the Compliance and Regulatory functions to ensure compliance to appropriate ISO, FDA standards, plan for and manage external audits and support product requests and submissions.
• Leads site quality teams to ensure alignment to the respective operations strategies, support lean efforts and drive quality improvement performance for products, processes and/or services across the site.

Job Requirements:

• BS in Chemical Engineering
• Minimum 15 years of progressive experience leading quality system and product quality improvement efforts, in the medical device/pharmaceutical/bioprocessing
• Minimum 10 years Quality Management Systems leadership in the medical device industry
• Minimum 10 years of experience leading multi-sites, multi-countries and functional Quality implementation and improvements
• Hands on analytical testing experience in a regulated laboratory

Preferred Qualifications

• Master’s degree
• Advanced knowledge of QMS, domestic and international regulations, international standards, industry standards, risk management, validation processes.
• History of leadership, communication and problem-solving for managing quality teams and ensuring compliance.
• Experience in strategic management, leading diverse teams, aligning stakeholders and navigating complex regulatory and product landscapes.
• Experience in data-driven decision making, process optimization, continuous improvement, problem solving, metrics, KPI development and management.
• Understanding and hands-on experience of the chemistries involved in medical device/pharmaceutical/bioprocessing product development and manufacturing.
• Experience in prioritizing Customer satisfaction by understanding and meeting/exceeding Customer expectations for product quality and performance.