Quality 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 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.

What You’ll Do as a Quality Analyst

• Coordinate day‑to‑day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
• Responsible for oversight of all product and/or report pre‑reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
• 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.
• Initiate and/or participate in corrective actions, problem‑solving and continuous improvement activities.
• 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.
• Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
• 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.
• 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).
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Perform other duties as assigned.

Education Degree

• Bachelor's Degree in Science

The Experiences, Skills, and Abilities Required

• Bachelor's degree in science or related technical field.
• 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 1-5 years of experience with medical devices or other regulated industries preferred.
• 1-5 years of experience working in an ISO certified environment required.
• Working knowledge of FDA QSR/EU GMP regulations strongly preferred.

This posting is for an existing vacancy within our organization.

Pay range for this opportunity is $66,000 - $84,000. This position is eligible for bonus participation, with an annual bonus opportunity of 7.5% of your fiscal year compensation, subject to the Bonus Plan’s terms and conditions.

STERIS strives to be an Equal Opportunity Employer. STERIS is committed to treating all people in a way that allows them to maintain their dignity and independence. We believe in integration and equal opportunity. Accommodations are available throughout the recruitment process and applicants with a disability may request to be accommodated throughout the recruitment process. We will work with all applicants to accommodate their individual accessibility needs.