Quality Analytics Analyst

The Quality Analytics Analyst is responsible for assisting in administration of the quality analytics function to support the STERIS AST Quality and Operations analysis function globally. This position assists with the development and implementation of quality and operational analysis and reporting in various systems to support management review and decision-making. This position is active in supporting performance improvement initiatives and provides inputs for analysis that is
presented to senior management and local site management across all AST facilities. The individual is responsible for completing assigned reporting and analytic requirements provided by internal and external Customers.

The role is responsible for the reporting and analysis that supports the quality system to be compliant with, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role supports local site efforts focused on quality system improvement, supplier quality, process quality, new service/modality/technology development quality and quality system compliance. The Analyst, Quality Analytics supports and provides input to the preparation of the senior management review function and reporting to allow sites to meet all applicable regulatory standards.

This role supports complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role also supports production and quality operations by coordinating and performing problem-solving investigations as assigned and reviews and analysisof quality system functions such as non-conformances, damages, calibration, dosimetry results, etc.

This is a hybrid position. The schedule is Monday- Friday, 8 AM - 5 PM, with a requirement of working on-site on Mondays, Tuesdays, and Thursdays.

• Coordinate individual day-to-day tasks to complete recurring (Monthly/Quarterly/Annually) reporting requirements for Quality Analytics function.
• Responsible for executing data refreshes and reporting updates at regular intervals to maintain accurate reporting for quality operations.
• Responsible for providing reporting and analytics for non-conformance trending across all
• Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
• Travel to AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives.
• Perform internal reviews of data trends among multiple systems, create reporting to illustrate data trending issues, and develop and execute actions to remediate any negative data trends as assigned by the Manager, Quality Analytics.
• Create or amend process documentation for reporting within the Quality Analytics functionand provide input to Quality Operations work instructions where applicable.
• Review collected data to perform statistical analysis and recommend process changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities within the company on quality relatedissues.
• Support development of reports to enhance the STERIS quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
• Overall responsibilities include commitment to ensure the accuracy of reporting data and analytics to meet external and internal requirements according to documented policies, procedures, standards and regulations.
• Perform other duties as assigned.

• 1-5 years of combined statistical analysis and/or data management and analytics experience.
• 1-5 years of experience with medical device or other regulated industries preferred.
• 1-5 years of experience working in an ISO certified environment required.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.