Quality Analytics Analyst
STERIS is a company dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. The Quality Analytics Analyst will assist in the administration of the quality analytics function, focusing on reporting and analysis to support management decision-making and quality system compliance across various standards.
Responsibilities
- 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 function and 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 related issues
- 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
Skills
- Bachelor's Degree
- 1-5 years of combined statistical analysis and/or data management and analytics experience
- 1-5 years of experience working in an ISO certified environment
- 1-5 years of experience with medical device or other regulated industries
- Working knowledge of FDA QSR/ EUGMP regulations
- Advanced knowledge of data analytics tools such as SQL, Tableau, Minitab, etc
Benefits
- STERIS offers a comprehensive and competitive benefits portfolio.
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