Director, Quality (Mentor, OH or Plymouth, MN onsite based)

The Director, Quality is responsible for leading multiple manufacturing/service sites and/or corporate quality resources in the execution of the overall STERIS Quality System. This position is principally responsible for manufacturing/service site or functional quality system execution to drive product/service quality improvement and ensure compliance with, as appropriate, ISO 9001, ISO 13485, MDSAP, FDA QMSR CFR Part 820/211, EU MDR, and other applicable standards. Supporting the GI Reprocessing business, this role provides quality leadership for products, processes, and services that help healthcare providers safely clean, disinfect, and reprocess gastrointestinal endoscopes and related equipment. The Director will champion a culture of quality, compliance, and continuous improvement, helping ensure the delivery of safe, effective, and reliable solutions that support infection prevention, patient safety, and customer confidence. The Quality Director will lead teams of quality managers and engineers responsible for product and service quality, supplier quality, new product/service support, continuous improvement initiatives, and quality system execution. This leader will partner closely with Operations, Engineering, Regulatory Affairs, and Commercial teams to drive operational excellence, mitigate risk, support innovation, and enhance quality performance across the GI Reprocessing portfolio.

Preferred onsite location: Mentor, OH, with consideration for candidates based in Plymouth, MN or Conroe, TX.

What You’ll do as a Director Quality

• ◆The Director, Quality will have responsibility for the following: Leads manufacturing/service sites and/or corporate quality staff in the execution and continuous improvement of the STERIS Quality System. Operates with a focus on the following objectives:
• ◆Ensures site level compliance to appropriate ISO, FDA, and other applicable regulatory standards.
• ◆Drives strategies and methods to continuously improve capital, consumable and service product quality performance.
• ◆Establishes clear and consistent quality measurement systems in order to monitor and drive results.
• ◆Leads quality planning and the execution of assigned New Product/Service Development (NPD) projects to achieve targeted quality deliverable adherence.
• ◆Drives targeted supplier quality improvement efforts and oversees supplier evaluation, approval, and control for assigned manufacturing sites.
• ◆Assists in the continuous improvement and standardization of quality system procedures and monitor effectiveness.
• ◆Supports the reliability function by integrating design for reliability tools and techniques within the local projects.
• ◆Leads quality planning efforts through cross-functional teaming at a site level.
• ◆Supports the New Product/Service Development process and projects to ensure projects attain cost, quality, and delivery objectives.
• ◆Directs local staff on planning sequential and concurrent quality activities. Establish planning and monitoring tools and techniques.
• ◆Provides Quality viewpoints and opinions in planning and specifying existing and future products.
• ◆Assists in the development of the Quality budget. Helps to ensures resources are adequate to fully support the Quality System.
• ◆Takes ownership of all local quality issues, projects, and development activities. Works closely with the site’s Senior Management Teams to provide strategic direction and development of the manufacturing sites product quality strategies and tactics.
• ◆Manages and provide direction to a teams of quality professionals both at corporate and manufacturing sites, with responsibility for hiring, performance management, appropriate staffing, and deployment of resources.
• ◆Assures that local sites maintain and improve operational and quality systems to remain in a state of compliance to appropriate ISO, FDA, and other applicable regulatory standards.
• ◆Works closely with the regulatory function to ensure compliance to appropriate ISO and FDA standards; plans for and assists in the management of external audits.
• ◆Leads manufacturing and service site quality teams to ensure alignment to operations, support of Lean efforts and drive quality improvement performance for products, services, and processes across the sites.
• ◆This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

• ✓Bachelor’s Degree (Engineering or related technical field)
• ✓Minimum 10 years of experience with increased responsibility leading quality system and product quality improvement efforts. Exceptional leadership manifested through organizing and motivating teams toward their respective goals by employing hands-on management.
• ✓Must fulfil the experience

listed in Article 15 of the EUMDR (PRRC).

• ✓A solid quality foundation indicated by a demonstrated understanding of Lean/Six Sigma, quality system, and product/process improvement methodologies.
• ✓Solid business acumen and proven ability to build and lead process and product improvement strategies and results.
• ✓Strong expertise in analytical methods, quality systems, and continuous improvement methods.
• ✓Excellent interpersonal, as well as verbal and written communication skills in order to develop and maintain rapport and effective internal and external relationships to support business success.
• ✓The ability to work hard and deliver results under pressure, as well as the willingness to address and shift priorities in rapidly changing markets.