Position SummaryThe Quality Analyst is responsible for assisting in administration of the quality analytics function to support the STERIS AST Quality and Operations 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 input 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 Quality Analyst 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 analysis of quality system functions such as non-conformances, damages, calibration, dosimetry results, etc.
This is a hybrid role with the requirement of working onsite in Mentor, OH 3 days/week. The onsite days are Monday, Tuesday, and Thursday. The remote days are Wednesday and Friday.
This role is
not eligible for Visa Sponsorship or H1B Transfer.
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.
- Support the migration and ongoing transition to Tableau Cloud and other data reporting sources, ensuring continuity and performance optimization of reporting capabilities. Including but not limited to writing and interpreting SQL queries to extract, manipulate, and analyze data from various sources.
- Design, develop, maintain, and enhance Tableau dashboards and workbooks to meet evolving business needs. Implement data blending and integration techniques to create comprehensive and insightful visualizations.
- Responsible for providing reporting and analytics for nonconformance, damage, re-read, Customer complaint and other quality event trending across all 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 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 for 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 to understand data requirements, reporting needs to deliver actionable insights and translate them into effective data solutions
- 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.
The Experience, Skills, and Abilities NeededRequired- Bachelor's Degree in Scientific or related technical field.
- 1-5 years of combined statistical analysis and/or data management and analytics experience.
- Must have advanced knowledge of data analytics tools such as SQL, Tableau, Minitab, etc.
- Must have PC experience, as well as advanced knowledge of desktop applications including Excel, Word, and PowerPoint. and advanced knowledge of data analytics tools in Excel.
Preferred- 1-5 years of experience with medical device or other regulated industries.
- 1-5 years of experience working in an ISO certified environment.
- Working knowledge of FDA QSR/ EUGMP regulations strongly.
Other- Excellent problem-solving skills.
- Excellent data analytics and critical thinking skills.
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on own initiative.
- Ability to apply feedback constructively across various situations.
- Demonstrated excellent organizational, oral and written communications 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.
What STERIS OffersWe value our employees and are committed to providing a comprehensive benefits package that support your health, well-being, and financial future.
Here is just a brief overview of what we offer:
- Market Competitive Pay.
- Extensive Paid Time Off (PTO) and 9 added Holidays.
- Excellent Healthcare, Dental and vision benefits.
- Long/Short Term Disability coverage.
- 401(k) with a company match.
- Maternity & Paternity Leave.
- Additional add-on benefits/discounts for programs such as Pet Insurance.
- Tuition Reimbursement and continued educations programs.
- Excellent opportunities for advancement in a stable long-term career.
STERIS does not accept unsolicited resumes/CV's from individual recruiters or third-party recruiting agencies in response to job postings.
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Pay range for this opportunity is $75,000 - $92,000. 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.
