Quality Specialist

STERIS; Roma; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

STERIS in Rome, Italy seeks a Quality Specialist to support quality functions ensuring compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. The role coordinates document control, site record retention, calibration, inspection, and supports risk management activities.

You will facilitate customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments, and help track quality data for management reviews.

Competenze

• Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
• Customer-first mindset with a sense of urgency
• Collaborates with others. Works in a professional manner to support team actions
• Effectively manages work tasks
• Detail oriented and strives for continuous improvement
• Ability to analyze technical issues
• Ability to cope with change and shifting priorities
• Constructs clear written communication
• Keeps manager and co-workers informed

Mansioni

• Complete document control transactions.
• 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.
• Support targeted Lean activities.
• Complete other duties as assigned.

Conoscenze

Customer focus

Urgency mindset

Collaborative

Task management

Detail oriented

Continuous improvement

Technical analysis

Adaptability

Written communication

Formazione

Associate's Degree

Descrizione del lavoro

Position Summary

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.

Duties

• Complete document control transactions.
• 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.
• Support targeted Lean activities.
• Complete other duties as assigned.

Education Degree

Associate's Degree

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.
• Effectively manages work tasks.
• Detail oriented and strives for continuous improvement.
• Ability to analyze technical issues.
• Ability to cope with change and shifting priorities.
• Constructs clear written communication.
• Keeps manager and co-workers informed.