Quality Specialist

Pomezia, Rome (Roma), Lazio, Italy
The Quality Specialist 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 coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

• Manage Customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Coordinate internal and external audits.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.
• Complete other duties as assigned.

Required Experience & soft skills
Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
Collaborates with others. Works in a professional manner to support team actions.
Detail oriented and strives for continuous improvement.
Ability to analyze technical issues.
Ability to cope with change and shifting priorities.
Keeps manager and co-workers informed.
PC experience and working familiarity of common desktop applications including Excel and Word.

In line with our commitment to transparency and equal pay, we provide the following information:
Chimica , Concia e settori accorpati, CONFAPI.
This position is eligible for corporate bonus .

This position requires knowledge of English due to the nature of the duties involved, including regular communications outside the province of Quebec, training, email communications, and frequent meetings and interactions with English- only employees. The employer has taken all reasonable steps to avoid imposing this language requirement, in accordance with the Charter of the French Language.
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 .
STERIS strives to be an Equal Opportunity Employer.
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