Quality Analytics Analyst

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

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.

What You'll Do as a Quality Analytics Analyst

• 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.

Education Degree

Bachelor's Degree

The Experience, Abilities, and Skills Needed

• 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.
• Advanced knowledge of data analytics tools such as SQL, Tableau, Minitab, etc. is preferred.
• This role requires on-site work in Mentor, Ohio on Mondays, Tuesdays, and Thursdays, with remote work available on Wednesdays and Fridays.

Pay range for this opportunity is $72,000 - $90,000. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.