Quality Systems & Compliance Lead: CAPA & Audits

Freseniusmedicalcare; Palazzo Pignano; In loco; EUR 36.000 - 42.000; Tempo pieno

Vantaggi offerti da questo lavoro

Career development opportunities

Innovative culture

Competitive base salary €36.000–€42.0

Descrizione del lavoro

Fresenius Medical Care in Northern Italy's Palazzo Pignano plant is seeking a Quality System and Compliance Expert to lead the NC/CAPA process and drive quality engineering activities.

You will support validation, change control, audits, and maintain documentation within the QMS, collaborating with Quality, Engineering and Production to improve processes and ensure regulatory compliance. Fluent Italian and English required.

Competenze

• Completed scientific, medical, or technical education (or equivalent).
• Minimum 3 years of professional experience, including Quality Assurance, ideally in medical devices, pharmaceuticals, or another regulated industry.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and validation methods.
• Knowledge of single-use sterilized medical devices.
• Fluent in Italian and English.
• Good IT skills (MS Office, SAP, SharePoint, procurement and quality databases such as NC/CAPA and document management systems).
• Strong communication and presentation skills, with ability to build professional relationships across levels.
• Proactive, solution-oriented mindset and cross-functional collaboration.

Mansioni

• NC/CAPA management: oversees intake, investigation, root cause analysis, execution, and closure in line with KPIs.
• Training and user support: delivers NC/CAPA database training and supports investigations and complaint handling.
• Reporting & escalation: prepares NC/CAPA metrics and updates to management; defines escalation needs.
• Continuous Improvement: identifies gaps and drives process and system improvements with Quality, Engineering, Production and others.
• Quality System & Compliance: advises management on system effectiveness; supports quality reviews and risk assessments.
• V&V and Process Change: reviews and approves V&V plans; supports change control processes.
• Audit Support: acts as a reference point during internal, corporate, notified body, and authority audits.
• Documentation & Traceability: ensures complete, compliant documentation for audits, NC/CAPA, and QMS activities.

Conoscenze

NC/CAPA management

Training & user support

Reporting & escalation

Continuous improvement

Quality system & compliance

V&V & process change

Audit support

Documentation & traceability

Formazione

Scientific/technical education

Strumenti

MS Office

SAP

SharePoint

NC/CAPA databases

Document management systems

Procurement systems

Descrizione del lavoro

Fresenius Medical Care in Northern Italy's Palazzo Pignano plant is seeking a Quality System and Compliance Expert to lead the NC/CAPA process and drive quality engineering activities.

You will support validation, change control, audits, and maintain documentation within the QMS, collaborating with Quality, Engineering and Production to improve processes and ensure regulatory compliance. Fluent Italian and English required.