Quality Systems Engineer – QMS & Compliance for Med Devices

vVardis AG; Zug; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

vVARDIS AG, based in Zug, Switzerland, seeks a Quality System Engineer to support and optimize the company’s QMS across OTC drugs, medical devices and cosmetics. You will help maintain the eQMS, run audits, and improve governance and training processes.

The role requires collaboration with Regulatory, R&D, and Manufacturing, with a focus on audit-readiness and metrics-driven quality performance. English fluency is essential.

Qualifikationen

• Degree in Life Sciences, Engineering, Quality Management, or related field.
• 3+ years of experience in a quality systems role within a regulated industry.
• Hands-on experience with an eQMS platform (document control, CAPA, audits, training).
• Lead auditor certification is a strong asset.
• Knowledge of ISO 13485, ISO 9001, EU MDR, GMP.
• Experience building dashboards from quality data (Excel/Power BI).
• Strong organizational skills and attention to detail.
• Fluent in English; additional European languages are an advantage.

Aufgaben

• Support the administration, configuration, and maintenance of the existing eQMS; support the future rollout of a new eQMS under the Quality Systems Manager.
• Prepare, coordinate, and follow up on Management Review, including consolidating quality metrics and inputs from process owners.
• Plan, schedule, and conduct internal quality audits across the quality system and product lines (OTC drugs, medical devices, cosmetics).
• Support document change management activities, including initiation, impact assessment, review, and closure of change requests within the eQMS.
• Manage and support process-related CAPAs, including root cause analysis, action plan tracking, and effectiveness checks.
• Support the training process, including maintaining training matrices and ensuring training records are current in the eQMS.
• Design, build, and maintain quality system dashboards and metrics to provide visibility into quality system health.
• Assist in preparing for external audits and regulatory inspections as they relate to the quality system.
• Monitor quality system KPIs and elevate risks or non-conformances to the Quality Systems Manager.
• Contribute to continuous improvement initiatives across the quality system.
• Maintain up-to-date knowledge of applicable quality standards and regulations (ISO 13485, ISO 9001, GMP, EU MDR).

Kenntnisse

eQMS

Audits

ISO 13485

Quality reporting

Cross-functional collaboration

English fluency

Ausbildung

Bachelor's degree (Life Sciences)

Engineering

Quality Management

Tools

Excel

Power BI

Jobbeschreibung

vVARDIS AG, based in Zug, Switzerland, seeks a Quality System Engineer to support and optimize the company’s QMS across OTC drugs, medical devices and cosmetics. You will help maintain the eQMS, run audits, and improve governance and training processes.

The role requires collaboration with Regulatory, R&D, and Manufacturing, with a focus on audit-readiness and metrics-driven quality performance. English fluency is essential.