Quality Systems Engineer – Medical Devices & eQMS Lead

vVardis AG; Zug; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

vVARDIS AG, based in Zug, Switzerland, seeks a Quality Systems Engineer to own QMS gap assessment and improvement programs, lead the eQMS replacement and manage internal audits across medical devices, OTC drugs and cosmetics.

You will report to Quality Management and collaborate with cross-functional teams to prepare for external audits and ensure ongoing QMS compliance with ISO 13485 and applicable standards.

Qualifikationen

• Degree in Life Sciences, Engineering, Quality Management or related field.
• Hands-on quality systems work in medical devices or related industry.
• Fluent in English (written & spoken).
• Experience with ISO 13485 and QMS audits.
• Hands-on experience with an eQMS platform (document control, CAPA, training).
• Knowledge of regulatory frameworks (EU MDR, FDA QMSR) is a plus.

Aufgaben

• Own the QMS gap assessment and improvement program against ISO 13485 and regulatory requirements.
• Lead the eQMS replacement project, including validation planning and data migration.
• Coordinate internal audits and support external audit readiness and responses.
• Define systemic actions for CAPAs and track improvements to completion.
• Maintain up-to-date knowledge of quality standards and regulations.

Kenntnisse

Quality systems expertise

Fluent English

Ausbildung

Degree in Life Sciences, Engineering, Quality Management or related field

Tools

eQMS platform (document control)

GAMP 5

21 CFR Part 11

Jobbeschreibung

vVARDIS AG, based in Zug, Switzerland, seeks a Quality Systems Engineer to own QMS gap assessment and improvement programs, lead the eQMS replacement and manage internal audits across medical devices, OTC drugs and cosmetics.

You will report to Quality Management and collaborate with cross-functional teams to prepare for external audits and ensure ongoing QMS compliance with ISO 13485 and applicable standards.