Quality Systems Engineer - CAPA, Audits & QMS Lead

Medartis; Basel; Hybrid; CHF 110,000 - 140,000; Full time

Job summary

Medartis in Basel, Switzerland, is seeking a Quality Systems Engineer to strengthen the Quality Management System team, focusing on CAPA administration, audits, and QMS enhancements. The role requires a BS in Engineering or related field, knowledge of ISO 13485 and FDA 21 CFR 820, and strong analytical/problem-solving skills.

The successful candidate will support corrective action programs, assist in internal and external audits, gather KPI data, and help maintain documentation controls within

Qualifications

• BS in Engineering or related field; or equivalent in experience
• Working knowledge of ISO 13485 and FDA 21CFR820
• Strong analytical and problem-solving skills

Responsibilities

• Act as CAPA administrator, facilitating CAPA system, timelines, and CAPA log management
• Manage external audit activities including certification audits and customer audits
• Facilitate all internal audit activities, planning resources and schedules
• Gather and manage KPI/metric data used to measure the QMS
• Assist QMR in annual quality management reviews per ISO 13485:2016
• Create/update procedures and work instructions to capture improvements to QMS processes
• Assist SMEs in developing and releasing procedures and work instructions
• Maintain document controls and change controls within the QMS
• Ensure processes and documentation comply with quality system regulations

Skills

CAPA administration

Audit management

QMS data analysis

Root cause analysis

Problem solving

Microsoft Office

Education

BS in Engineering

Tools

CAPA software

Document control systems

QA management software

Job description

Medartis in Basel, Switzerland, is seeking a Quality Systems Engineer to strengthen the Quality Management System team, focusing on CAPA administration, audits, and QMS enhancements. The role requires a BS in Engineering or related field, knowledge of ISO 13485 and FDA 21 CFR 820, and strong analytical/problem-solving skills.

The successful candidate will support corrective action programs, assist in internal and external audits, gather KPI data, and help maintain documentation controls within