Quality Specialist Lazio

Quality Specialist
Roma
Lazio, Lazio

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 Associate Quality Specialist position is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.

This role processes document control transactions, coordinates site record retention, assists in calibration activities, supports inspection and auditing tasks and assist in other Quality Management System support activities.

**Duties**:

- Process document control transactions.

- Review DHR's and support batch record release.

- Support the record retention practices within the site.

- Coordinate site calibration activities and recordkeeping.

- Coordinate site inspection activities and recordkeeping.

- Support internal and external auditing processes.

- Support targeted Lean activities.

- Complete other duties as assigned.

**Duties - cont'd**:

**Education Degree**:

- High School Diploma or GED

- Associate's Degree

**Required Experience**:

- One (1) year experience preferred in a regulated industry (i. e.

FDA/ISO 13485)

- Associate's degree in related technical field (i. e.

Engineering, Chemistry, Biology) preferred.

**Preferred Experience**:

**Skills**:

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.

We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD.

STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16, 000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.