Quality Analytics Analyst

Isomedix Operations Inc. (US)•Mentor, OH

7d•$75,000 - $92,000•Hybrid

About The Position

The Quality Analytics Analyst assists in administering the quality analytics function supporting STERIS AST Quality and Operations globally. The role develops and implements quality and operational analysis and reporting across systems to support management review and decision-making, performance improvement initiatives, and reporting requirements from internal and external customers. It supports quality-system compliance with applicable standards and regulations, including ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, and/or ISO 11135. The analyst supports site efforts involving quality-system improvement, supplier and process quality, new service/modality/technology development quality, and regulatory compliance. The role contributes to senior management reviews and supports complaint and CAPA investigations, supplier quality improvement, continuous improvement, and production and quality operations problem-solving. It reviews and analyzes quality-system functions such as non-conformances, damages, calibration, and dosimetry results. This is a hybrid role 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. The role may require domestic and/or global travel to AST facilities for remediation, audits or inspections, and continuous improvement initiatives.

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 continuous improvement.
Experience working on cross-functional teams and independently taking initiative.
Ability to apply feedback constructively across 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 other regulated industries.
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 to complete recurring monthly, quarterly, and annual quality analytics reporting.
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, including continuity and performance optimization.
Write and interpret SQL queries to extract, manipulate, and analyze data from various sources.
Design, develop, maintain, and enhance Tableau dashboards and workbooks; use data blending and integration to create 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/or 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 illustrating issues, and develop and execute assigned actions to remediate negative trends.
Create or amend reporting process documentation and provide input for Quality Operations work instructions where applicable.
Analyze collected data statistically and recommend process changes to improve quality.
Monitor and report 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 needs and translate them into actionable data solutions.
Support 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.