Director, Quality Systems (Remote)

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Director, Quality Systems is responsible for leading, planning, developing, and directing quality operations policies, programs, initiatives, and overall execution of the STERIS QMS within multiple facilities spread across geographical regions and countries. This position is fundamentally responsible for quality system execution and compliance within a complex network of technologies/modalities that operate within a heavily regulated environment and serve a diverse Customer-base with significant variance in product mix. The Director, Quality Systems has ultimate decision-making authority over the release and shipment of all product processed and laboratory results within their respective facilities. The Director’s decision-making authority also extends beyond product and laboratory sample release to matters involving Regulators and Customers. The Director accepts the responsibility and risk for processed products and samples tested as being in compliance with all regulatory and company standards, including 21 CFR Part 820, Part 211, Part 1271.150, Part 211, ISO 11135, ISO 11137, ISO 13485, ISO 17025 and other country-specific standards and regulations. The Director, Quality Systems leads teams of Senior Quality Managers, Quality Managers, Analysts/Engineers, and Technicians responsible for product quality, product release, supplier quality, continuous improvement support, technical support/technical guidance, and quality system execution. Leadership responsibilities extend to ensuring all quality operations goals, objectives, strategies, and tactics align and promote growth, operational excellence, Customer focus, and leadership excellence. The Director is a member of the AST Management Team and serves as the Management Representative for their respective facilities. In this capacity, the Director is expected to make an essential and active contribution to the overall performance of AST by evaluating the performance of production and quality system processes to improve exiting methods, process, and operations. 

What You’ll do as a Director, Quality Systems

• Lead and direct Quality Managers and their staff to ensure QMS activities across their multiple facilities are consistent with Advanced Sterilization Technology (AST) goals and objectives. This is accomplished through systematic identification of opportunities for improvement and the diligence to ensure actions required as a result of audits, nonconformance, system deviation, Customer concerns and complaints are responded to timely and in a manner that meets the requirements of the QMS, regulations/standards and AST objectives.
• Lead all regulatory authority inspections in assigned facilities to ensure investigator requests are met in a timely manner with the highest level of professionalism. Responsible for any remediation required as a result of an inspection immediately with a corrective plan to first direct the timely implementation at the inspected facility followed by a comprehensive assessment of the global facilities to identify and correct systemic findings.
• Create and critically assess the impact of QMS procedures, global work instructions, and local work instructions on the daily operations of the facilities. Working alongside Quality & Regulatory Compliance and Operations management, identify opportunities for improvement and efficiency while ensuring the spirit of the regulations that govern AST are never compromised.
• Direct large, cross-functional, and often global programs in support of Quality Operations and AST initiatives. by developing thorough and thoughtful control plans with repeatable and sustainable actions to be implemented in all facilities within their respective zone and globally.
• Resolve escalating quality operations problems/concerns with site Quality Managers/Regional Quality Managers and others including vendors, Customers, Operations and Regulators requiring the ability to manage complex relationships with key stakeholders.
• Analyze, evaluate, and present performance metrics concerning execution and performance on the QMS to Senior Leadership and Executive team. Support Senior Leadership and Executive team in establishing strategies designed to align and effectively execute on operations, quality system, commercial and Customer requirements.
• Ensure that their respective facilities maintain and improve operational and quality systems to remain in a state of compliance to applicable ISO, Regulatory Agency and Customer regulations and stand