Senior Quality Assurance Specialist

4 days ago


Edmonton, Alberta, Canada STERIS Full time

At STERIS, we strive to create a healthier and safer world by providing innovative healthcare solutions globally.

About the Role

We are seeking a Senior Quality Assurance Specialist to join our team. This is an onsite schedule position with dayshift hours and requires 5-10% international and domestic travel.

Responsibilities
  1. Coordinate daily tasks and direction for quality technicians by providing technical support, mentoring, and oversight.
  2. Oversee all product and/or report pre-reviews and releases conducted by quality technicians.
  3. Execute product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of customer communication and leading associated non-conformance investigations.
  4. Initiate and participate in corrective actions, problem-solving, and continuous improvement activities.
  5. Perform internal audits at other AST facilities, identifying non-compliances and generating reports.
  6. Manage creation of new quality system policies and procedures, as well as 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 (calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
Requirements
  • Bachelor's Degree.
  • 1-5 years of combined manufacturing/quality engineering and/or quality systems experience.
  • 1-5 years of experience working in an ISO certified environment.
Preferred Qualifications
  • Working knowledge of FDA QSR/EUGMP regulations strongly preferred.
  • 1-5 years of experience with medical device or other regulated industries preferred.
Salary and Benefits

The estimated salary for this role is $65,000 - $85,000 per year, depending on location and experience. STERIS offers a comprehensive benefits package, including health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.



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