Quality Systems Engineer

vVARDIS; Zug; Presencial; CHF 110.000 - 150.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality systems expertise

Fluent English

Educación

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

Herramientas

eQMS platform (document control)

GAMP 5

21 CFR Part 11

Descripción del empleo

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 Systems Engineer in the Quality Systems function, you are the hands-on engineer for the design, improvement and validation of the company's Quality Management System (QMS), which covers medical devices, OTC drug products and cosmetics. You report to the Director, Quality Management, and work day to day with the Manager, Quality Systems, who owns document control, training, the CAPA system and the internal audit program.

Your three main areas are the QMS gap assessment and improvement program, which you own; the replacement of the eQMS, where you are the technical lead and responsible for computer system validation; and the internal audit program, where you act as lead auditor. You also prepare the quality system for external audits and inspections and assess the impact of new and revised QMS standards and regulations.

This is an individual contributor role at engineer level, with no direct reports and no budget responsibility. It suits a quality systems professional from the medical device industry who wants to do the quality systems work personally rather than lead a team.

Key Responsibilities:

QMS gap assessment and improvement program

• Own the QMS gap assessment and improvement program: plan and perform regular gap assessments of the QMS against ISO 13485, MDSAP requirements, FDA requirements (21 CFR 820 (QMSR) and 21 CFR 211) and other applicable regulations, for approval by the Director, Quality Management.
• Translate gap assessment results, audit findings and QMS performance data into prioritized improvement actions with clear owners and timelines, hand them over for implementation by the Manager, Quality Systems and the process owners, and track them to completion.
• Design and redesign QMS processes, including the SOP lifecycle and document control process, and prepare the related design changes through QMS change control.
• Define systemic actions for CAPAs arising from audits and other QMS sources; execution is carried out by the Quality Engineer, CAPA & Process Improvement, and tracking by the Manager, Quality Systems.
• Identify opportunities to simplify, standardize or automate quality system processes, and verify that implemented improvements are effective.
• Provide input to the quality manual, quality policy and quality objectives, and report the status of the improvement program as input to the management review.

eQMS replacement and validation

• Act as technical lead for the eQMS replacement project, which is owned by the Director, Quality Management: define user requirements and map and harmonize current processes before they are configured in the system.
• Plan and lead the computer system validation of the eQMS in line with ISO 13485 clause 4.1.6 and 21 CFR Part 11, including validation plan, risk assessment, specifications, protocols and reports.
• Coordinate data migration and test execution, performed with the Quality Engineer, CAPA & Process Improvement, and ensure completeness and data integrity of migrated documents and records.
• Support go-live together with the key users from each function.
• After go-live, validate changes to the eQMS (upgrades, configuration changes, new modules) to keep the system in a validated state, in agreement with the Manager, Quality Systems as system owner.

Internal audits and external audit readiness

• Act as lead auditor in the internal audit program owned by the Manager, Quality Systems: prepare, conduct and report internal audits across all functions, working with co-auditors from Quality Systems and Quality Operations.
• Ensure ongoing readiness of the quality system processes, documentation and records for external audits and inspections (e.g., notified body, MDSAP auditing organization, FDA, Swissmedic).
• Support external audits and inspections, in which the Director, Quality Management leads the front room and the Manager, Quality Systems leads the back room.
• Prepare responses to quality system audit findings and follow up the resulting actions within committed timelines.

QMS standards impact assessment

• Assess the impact of new and revised QMS standards and regulations (e.g., ISO 13485, 21 CFR 820 (QMSR), 21 CFR 211, 21 CFR Part 11, MDSAP, QMS requirements of the EU MDR) identified through the Standards Management process owned by Regulatory Affairs.
• Define the resulting QMS changes for implementation by the Manager, Quality Systems, and share relevant updates with affected process owners.
• Maintain up-to-date knowledge of quality standards and regulations applicable to medical devices, OTC drug products and cosmetics.

Required Qualifications & Experience

Must have

• Degree in Life Sciences, Engineering, Quality Management or a related field.
• 3 to 8 years of professional experience in quality, of which at least 3 years in a hands-on quality systems role at a medical device manufacturer operating an ISO 13485 certified QMS.
• Current or most recent position at specialist or engineer level (e.g., QMS Specialist, Quality Systems Engineer, QA Engineer), doing quality systems work personally.
• Practical working knowledge of ISO 13485 and of at least one of EU MDR, MDSAP or 21 CFR 820 (QMSR), applied in daily work rather than only through training.
• Hands-on experience with an eQMS platform (e.g., document control, change management, CAPA, audit and training modules).
• Experience in computer system validation (e.g., ISO 13485 clause 4.1.6, GAMP 5, 21 CFR Part 11), including writing and executing validation protocols.
• Hands-on experience conducting internal audits in a medical device QMS.
• Fluent in English (written and spoken).

Nice to have

• Lead auditor certification (ISO 13485 or MDSAP).
• Experience supporting the rollout of a new eQMS, including data migration.
• Additional experience with GMP for OTC drug products (21 CFR 211) or cosmetics (ISO 22716), in addition to medical device experience.
• Experience building reports or dashboards from quality system data (e.g., in Excel, Power BI or the eQMS's native reporting tools).
• German or other European languages.
• Strong organizational skills, with the ability to manage multiple quality system processes and deadlines while maintaining alignment with the line 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 escalation 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

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.