Advanced Quality Engineer

The Advanced Quality Engineer has principal responsibility for managing highly complex projects involving the STERIS Quality Management System, service or manufacturing process quality improvements or technical product or service quality improvement. These projects require significant cross-functional participation and support from all levels in STERIS.

This role is tasked with leading

• acquisition or new site quality system integration
• acquisition or new site production and process control integration
• quality measurement system implementation
• business-wide quality system standardization
• product, service and manufacturing quality technical analysis and improvement.

This role may also have responsibility for leading and executing the quality strategy for multiple manufacturing or service production lines. The Advanced Quality Engineer is also responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards.

This position may require up to % Travel domestically.

• Leads the QMS integration of acquisitions or new manufacturing or service sites.
• Leads production and process control integration and improvement for acquisitions and new manufacturing or service sites.
• Leads Quality Management System design, implementation and improvement for new and existing manufacturing and service sites.
• Designs and implements quality measurement systems and improvements for new and existing manufacturing and service sites.
• Analyzes data and trends to ensure acceptance and effectiveness of site quality measurement systems.
• Leads business-wide Quality Management System standardization initiatives.
• Leads key manufacturing and service quality improvement initiatives and strategies.
• Leads and executes the quality strategy for multiple manufacturing or service production lines.
• Develops, implements, maintain and improves complex quality programs such as product and service quality, supplier controls and production/process controls.
• Develops and generate reports and analyses on quality improvement initiatives to present to senior management.
• Provides input to the annual Quality Planning Process.
• Instructs other STERIS employees in quality principles, such as quality systems, problem solving, and valid statistical techniques.
• Directs the work of Quality and other cross-functional staff in the execution of key projects and initiatives.
• Manages complex and ambiguous problems and formulates technical solutions.
• Provides team members and leadership with feedback and support on technical issues.
• Identifies and develops new technical ideas.
• Identifies risks and communicates effective mitigation strategies.
• Challenges existing processes and proactively seeks creative solutions to enhance performance.
• Gathers complex information from various sources and simplifies designs and procedures for better understanding.
• Leads a team to brainstorm solutions for routine technical issues, involving key individuals in the decision-making process.
• Makes effective decisions by considering cost, efficiency, and customer needs, even when data is limited.
• Designs adaptable solutions that align with broader strategic goals and respond to changes in technology and clinical use.
• Incorporates industry knowledge into technical solutions and influences the team's design and product development strategies.
• Fosters strong relationships with partners by promoting trust, considering input, and resolving issues collaboratively to ensure future partnerships.
• Coordinates strategies and resources across departments to maintain consistent communication and support organizational goals.
• Utilizes a collaborative style to negotiate win-win outcomes, effectively conveying complex information through visuals and listening to technical concerns.
• Anticipates customer needs and proactively provides solutions, developing tools that enhance project continuity and efficiency.

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Required

• Bachelor's Degree in Engineering.
• Minimum of 8 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems)
• 8+ years of experience working in an ISO certified environment

Preferred

• Experience with medical device or other regulated industries.
• ASQ, QSR or familiarity with QSR/GMP regulations