Quality Systems Engineer — CAPA & Audit Specialist

Medartis; Basel; On-site; CHF 90,000 - 140,000; Full time

Job summary

Medartis, based in Basel, seeks a Quality Systems Engineer to support the Quality Management System. You will act as the CAPA administrator, coordinate external and internal audits, and help maintain QMS documentation and controls.

The role requires a BS in engineering or related field or equivalent experience, plus knowledge of ISO 13485 and FDA 21 CFR 820, with strong analytical and root-cause analysis skills. Office proficiency is essential.

Qualifications

• CAPA processes and system knowledge is required.
• Audit management and liaison with external parties.
• Engage in internal audit planning and execution.
• Understanding QMS documentation and controls.

Responsibilities

• Act as CAPA administrator: initiate CAPA, track timelines, maintain CAPA log, report metrics, lead CAPA review board.
• Manage external audits (certification bodies and customer audits); liaise with parties, schedule, organize resources, communicate responses, report metrics.
• Facilitate internal audits: planning, resource assignment, schedule management, metrics.
• Gather and manage KPI/metric data for QMS.
• Assist QMR in annual quality management reviews per ISO 13485:2016.
• Create/update procedures and work instructions to improve QMS processes.
• Support subject matter experts in developing and releasing procedures and work instructions.
• Maintain document and change controls within the QMS.
• Ensure processes and docs comply with quality system regulations.

Skills

CAPA administration

Audit coordination

QMS data management

Root cause analysis

Analytical problem solving

MS Office

Education

BS in Engineering or related field preferred

Job description

Medartis, based in Basel, seeks a Quality Systems Engineer to support the Quality Management System. You will act as the CAPA administrator, coordinate external and internal audits, and help maintain QMS documentation and controls.

The role requires a BS in engineering or related field or equivalent experience, plus knowledge of ISO 13485 and FDA 21 CFR 820, with strong analytical and root-cause analysis skills. Office proficiency is essential.