Quality Systems Engineer

About the role

vVARDIS, a Swiss oral health company based in Zug, is looking for a Quality Systems Engineer. You will be the hands-on engineer for the design, improvement and validation of the company's Quality Management System (QMS), covering medical devices, OTC drug products and cosmetics. You report to the Director, Quality Management and work with the Manager, Quality Systems. This is an individual contributor role with no direct reports.

Key responsibilities

• Own the QMS gap assessment and improvement program: run regular gap assessments against ISO 13485, MDSAP, FDA requirements (21 CFR 820 QMSR and 21 CFR 211) and other regulations, turn results into prioritized improvement actions and track them to completion.
• Redesign QMS processes such as the SOP lifecycle and document control, and prepare design changes through QMS change control.
• Define systemic CAPA actions arising from audits; identify opportunities to simplify, standardize or automate quality processes.
• Act as technical lead for the eQMS replacement: define user requirements, plan and lead computer system validation under ISO 13485 clause 4.1.6 and 21 CFR Part 11, coordinate data migration and support go-live.
• Act as lead auditor in the internal audit program and ensure readiness for external audits (notified body, MDSAP, FDA, Swissmedic).
• Assess the impact of new QMS standards and regulations and define the required QMS changes.

Required profile

• Degree in Life Sciences, Engineering, Quality Management or a related field.
• 3 to 8 years of professional quality experience, including at least 3 years in a hands-on quality systems role at an ISO 13485-certified medical device manufacturer.
• Current or most recent specialist or engineer-level position doing quality systems work personally.
• Fluent English, written and spoken.

Required skills

• Practical knowledge of ISO 13485 and at least one of EU MDR, MDSAP or 21 CFR 820 (QMSR).
• Hands-on experience with an eQMS platform (document control, change management, CAPA, audit and training modules).
• Computer system validation (ISO 13485 4.1.6, GAMP 5, 21 CFR Part 11) and internal audits in a medical device QMS.
• Nice to have: lead auditor certification, eQMS rollout experience, GMP for OTC drugs (21 CFR 211) or cosmetics (ISO 22716), dashboard/reporting experience, German or other European languages.