Quality Systems Engineer

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 is a Swiss-based oral health company founded by Dr. Haley and Dr. Goly Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative vision of its founders.

At vVARDIS, we are committed to delivering innovative solutions that enhance oral health and well-being, inspired by the vision of our founders to foster preventive rather than reparative dentistry. At the heart of our Company lies its patented, revolutionary biomimetic peptide technology. Scientifically proven in over 200 publications, this unique technology can treat early caries through enamel regeneration, offering a non-invasive, pain-free solution for patients of all ages. Our portfolio includes oral health products for dental professionals, patients, and consumers, all based on our proprietary technology.

We value our people and believe in fostering a positive and collaborative work environment, grounded in our core values of innovation, excellence, integrity, and empathy.

We are located in Zug, Switzerland, with operations in Europe and the US. Join us on this exciting journey.

Purpose:

As Quality System Engineer, you will support the Quality Systems Manager in maintaining and continuously improving the company's Quality Management System (QMS), covering OTC drugs, medical devices, and cosmetics.

You will act as a key contributor to the day-to-day operation of the eQMS and its core processes. This will include management review, internal audits, change management of documents and training. Ensuring the quality systems remains compliant, effective, and audit-ready across all product categories. The role also includes supporting the future implementation of a new eQMS.

You will work cross-functionally with Regulatory, R&D, Manufacturing, and other departments to embed quality system requirements into daily operations, and will help drive visibility of quality performance through system dashboards and metrics.

Key Responsibilities:

• Support the administration, configuration, and maintenance of the existing eQMS, including workflows, user access, document control, and periodic system updates; support the future rollout of a new eQMS under the ownership of the Quality Systems Manager, with assigned activities defined in the project plan
• Support the Quality Systems Manager in preparing, coordinating, and following up on Management Review, including consolidating quality metrics and inputs from process owners
• Plan, schedule, and conduct internal audits across the quality system and product lines (OTC drugs, medical devices, cosmetics), including audit reports, findings tracking, and follow-up on corrective actions
• 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 facilitation, action plan tracking, effectiveness checks, and closure
• Support the training process, including maintaining training matrices, tracking completion, coordinating with process owners on training content, 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 (e.g., audit status, CAPA aging, training compliance, change request cycle times, complaint and deviation/non-conformance KPIs)
• Support document control activities, including review, approval routing, and periodic review/revision of SOPs, work instructions, and forms
• Assist in preparing for and supporting external audits and regulatory inspections (e.g., notified body, health authority) as they relate to the quality system
• Monitor quality system KPIs and elevate trends, risks, or non-conformances to the Quality Systems Manager
• Contribute to continuous improvement initiatives across the quality system, identifying opportunities to simplify, standardize, or better automate processes
• Maintain up-to-date knowledge of applicable quality standards and regulations (e.g., ISO 13485, ISO 9001, GMP, EU MDR, 21 CFR 820, 21 CRF 211, etc.) relevant to OTC drugs, devices, and cosmetics

Required Qualifications & Experience

• Degree in Life Sciences, Engineering, Quality Management, or a related field
• 3 or more years of experience in a quality systems role, ideally within a regulated industry (pharmaceuticals, medical devices, or cosmetics)
• Hands-on experience with an eQMS platform (e.g., document control, document change management, CAPA, audit, and training modules); experience supporting the rollout of a new eQMS is an advantage
• Hands-on experience conducting internal quality audits. Lead auditor certification is a strong asset
• Working knowledge of quality standards and regulatory frameworks applicable to OTC drugs, medical devices, and/or cosmetics (e.g., ISO 13485, ISO 9001, EU MDR, GMP)
• Experience building reports or dashboards from quality system data (e.g., in Excel, Power BI, or the eQMS's native reporting tools) is a strong advantage
• Strong organizational skills, with the ability to manage multiple quality system processes and deadlines while maintaining alignment with the manager on priorities and expected deliverables
• Strong attention to detail and a structured approach to documentation and record-keeping, with ownership of the accuracy and completeness of work
• Clear and concise written and verbal communication, with strong listening skills and the ability to clarify requirements and expectations before proceeding
• Openness to feedback, with the ability to translate it into practical improvements and adapt working methods when needed
• A diplomatic and collaborative approach to cross-functional work, with the ability to influence without direct authority and follow up effectively with process owners
• Proactive and able to work independently, while recognizing when to seek guidance, flag risks, or elevate issues
• Sound judgment and a constructive approach to problem-solving, with the ability to consider different perspectives, raise concerns, and follow through on agreed decisions and actions
• An analytical mindset, with the ability to interpret quality data and translate it into meaningful metrics and actionable insights
• Adaptability to changing priorities and business or regulatory requirements, while maintaining quality and a continuous improvement mindset
• Fluent in English (written & spoken); additional European languages an advantage

Your Personality:

You are a detail-oriented and ownership-driven quality professional who takes pride in doing things right. You are comfortable working hands-on with documentation, investigations, and processes, and you approach problems with a structured and analytical mindset. You communicate clearly, follow through on commitments, and understand that your work directly contributes to product safety and patient outcomes. You thrive in a collaborative team environment and are motivated by continuous improvement — both in the systems you work with and in yourself.