Job Description

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 Analyst is responsible for assisting in administration of the quality management system at a site to assure adherence to 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 leads 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 executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

This is a day shift position with a rotational schedule of supporting Operations 1 weekend per month.

Duties

1. Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
2. Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
3. Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations. 
4. Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
5. Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
6. Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
7. Review collected data to perform statistical analysis and recommend process changes to improve quality.
8. Monitor and report on performance metrics.
9. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
10. Collaborate with other departments and facilities within the company on quality related issues.
11. Lead 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).
12. Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations. 
13. Perform other duties as assigned.

Education Degree

• Bachelor's Degree in Science

Required Experience

1. 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
2. 1-5 years of experience with medical device or other regulated industries preferred.
3. 1-5 years of experience working in an ISO certified environment required.
4. Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
5. Bachelors Degree in Technical or Scientific field 

Preferred Experience

1. Excellent problem-solving skills
2. Focus on identification of potential issues and continuous improvement.
3. Experience working on cross-functional teams and on own initiative.
4. Demonstrated excellent organizational, oral and written communications skills.
5. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
6. Ability to work in a fast-paced, regulated environment with strict deadlines.
7. Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra. 

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Pay range for this opportunity is $78,500.00 - $83,000.

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 is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs 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.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

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