Hybrid Quality Associate - CAPA & NC Expert

SOPHiA GENETICS; Schweiz; Hybrid; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Helsana health coverage

CHF 90 comfort meal vouchers monthly

25 days vacation

Fitness partnerships

Rest & Entertainment space and free咖啡

Zusammenfassung

SOPHiA GENETICS is seeking a Quality Associate to support NC, CAPA and CCP processes in a contract role based in Rolle, Switzerland. The hybrid position requires in-office presence at least 3 days per week and spans through 31/05/2027.

You will manage NCs, CAPAs end-to-end and assist CCP activities while coordinating with Supply Chain, Procurement, Data Science and IT. English proficiency is essential for cross-functional collaboration in an international environment.

Qualifikationen

• Experience with CAPA, NC, CCP and quality documentation processes.
• Direct experience in Quality Control / Quality Assurance in a scientific/medical/pharma environment.
• Experience with ISO 9001 and ISO 13485 standards.
• Systems experience with ticketing and document management tools (Veeva & Jira).
• Fluent in English (written and spoken).

Aufgaben

• Close gaps by reviewing open and historical NCs to ensure audit readiness before inspections.
• Manage CAPAs end-to-end from root cause analysis through implementation and verification of effectiveness.
• Support CCP activities with proper assessment, documentation and approval before changes.
• Collaborate with Supply Chain, Procurement, Data Science and IT to gather evidence and close actions on time.
• Identify emerging non-conformities, assess risk and recommend remediation.
• Maintain audit-ready records in Veeva and Jira across quality processes.

Kenntnisse

CAPA

NC management

CCP

Quality documentation

Quality Assurance

ISO 9001

ISO 13485

English fluency

Tools

Veeva

JIRA

Jobbeschreibung

SOPHiA GENETICS is seeking a Quality Associate to support NC, CAPA and CCP processes in a contract role based in Rolle, Switzerland. The hybrid position requires in-office presence at least 3 days per week and spans through 31/05/2027.

You will manage NCs, CAPAs end-to-end and assist CCP activities while coordinating with Supply Chain, Procurement, Data Science and IT. English proficiency is essential for cross-functional collaboration in an international environment.