Quality Analytics Analyst

Isomedix Operations Inc. (US)•Mentor, OH

3d•$75,000 - $92,000•Hybrid

About The Position

The Quality Analytics Analyst assists in administering the quality analytics function to support STERIS AST Quality and Operations globally. The role develops and implements quality and operational analysis and reporting across various systems to support management review and decision-making, supports performance improvement initiatives, and provides analysis for senior management and local site management. The analyst completes assigned reporting and analytics requirements for internal and external customers. The position supports reporting and analysis that help maintain compliance with applicable standards and regulations, including ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other applicable regulatory standards. It supports local-site quality system improvement, supplier and process quality, quality for new services, modalities and technologies, and quality system compliance. The role also supports preparation of senior management reviews and reporting required for regulatory compliance. The analyst supports complaint and CAPA investigations, supplier quality and continuous improvement initiatives, and countermeasures using statistical techniques and accepted quality principles. The role also coordinates or performs assigned problem-solving investigations and reviews and analyzes quality system functions, including non-conformances, damages, calibration, and dosimetry results. This is a hybrid position requiring onsite work in Mentor, Ohio, three days per week: Monday, Tuesday, and Thursday. Wednesday and Friday are remote. The position is not eligible for visa sponsorship or H-1B transfer.

Requirements

Bachelor's degree in a scientific or related technical field.
1–5 years of combined statistical analysis and/or data management and analytics experience.
Advanced knowledge of data analytics tools such as SQL, Tableau, and Minitab.
PC experience and advanced knowledge of desktop applications, including Excel, Word, and PowerPoint; advanced knowledge of data analytics tools in Excel.
Excellent problem-solving, data analytics, and critical-thinking skills.
Focus on identifying potential issues and supporting continuous improvement.
Experience working on cross-functional teams and independently.
Ability to apply feedback constructively across various situations.
Excellent organizational, oral, and written communication skills.
Ability to work in a fast-paced, regulated environment with strict deadlines.
Mathematical skills, including practical application of statistical trending, fractions, percentages, ratios, proportions, and algebra.

Nice To Haves

1–5 years of experience in medical device or another regulated industry.
1–5 years of experience working in an ISO-certified environment.
Strong working knowledge of FDA QSR and EU GMP regulations.

Responsibilities

Coordinate day-to-day tasks for recurring monthly, quarterly, and annual Quality Analytics reporting requirements.
Execute data refreshes and reporting updates at regular intervals to maintain accurate quality operations reporting.
Support migration to and ongoing transition to Tableau Cloud and other reporting sources, maintaining continuity and optimizing reporting performance.
Write and interpret SQL queries to extract, manipulate, and analyze data from various sources.
Design, develop, maintain, and enhance Tableau dashboards and workbooks, including data blending and integration for business visualizations.
Provide reporting and analytics on nonconformance, damage, re-read, customer complaint, and other quality-event trends across STERIS AST, Healthcare, and Life Science facilities.
Initiate and participate in corrective actions, problem-solving, and continuous improvement activities.
Travel to AST facilities domestically and/or globally to support remediation, audits or inspections, and continuous improvement initiatives.
Review data trends across multiple systems, create reports showing trends, and develop and execute actions to remediate negative trends as assigned by the Manager, Quality Analytics.
Create or amend reporting process documentation and provide input for Quality Operations work instructions where applicable.
Review collected data, perform statistical analysis, and recommend process changes to improve quality.
Monitor and report on performance metrics.
Instruct STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
Collaborate with departments and facilities to understand data and reporting requirements, deliver actionable insights, and translate requirements into data solutions.
Support development of reports for quality system programs, including calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, and risk management.
Ensure reporting data and analytics are accurate and meet internal and external requirements under documented policies, procedures, standards, and regulations.