Quality Analyst

STERIS; London; On-site; CAD 60,000 - 80,000; Full time

Job summary

A healthcare product provider is seeking a Quality Analyst in London, Ontario to oversee quality management systems. The role involves coordinating quality technicians, managing product releases, and performing internal audits to ensure compliance with ISO standards. Candidates should possess a Bachelor's degree in science and 1-5 years of related experience in regulated industries. This position offers a chance to contribute to innovative healthcare solutions in a collaborative environment.

Qualifications

• Bachelor's degree in science or related technical field.
• 1-5 years of experience in Manufacturing/Quality Engineering.
• Experience in an ISO certified environment.
• Knowledge of FDA QSR/EUGMP regulations preferred.

Responsibilities

• Coordinate and mentor Quality Technicians.
• Execute product and report releases.
• Perform internal audits and manage findings.
• Lead quality system programs such as CAPA and complaints.

Skills

Manufacturing/Quality Engineering

Quality Systems

Statistical Analysis

Problem Solving

Education

Bachelor’s Degree in Science

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.

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

• Bachelor’s Degree in Science

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/EUGMP regulations strongly preferred.

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.