Quality Compliance Specialist – ISO & FDA

We are currently recruiting for a Quality Specialist. This is an excellent opportunity to join the business at a skilled professional level.

About the Role

The Quality Specialist will be responsible for assisting in administration of the quality functions on site to assure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions and site record retention. In addition, the Quality Specialist will assist in audit coordination and support validation and risk management activities where appropriate.

Responsibilities

• Process document control transactions.
• Review DHRs and support batch record release.
• Support record retention practices within the site.
• Coordinate site calibration activities and recordkeeping.
• Coordinate site inspection activities and recordkeeping.
• Support internal and external auditing...

Ready to Apply?

Submit your application today and join our talented team at STERIS.