Quality Systems Engineer in Zug

pvVARDIS 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. /p pAt 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. /p pWe value our people and believe in fostering a positive and collaborative work environment, grounded in our core values of innovation, excellence, integrity, and empathy. /p pWe are located in Zug, Switzerland, with operations in Europe and the US. Join us on this exciting journey. /p h3Purpose: /h3 pAs 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. /p pYour 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. /p pThis 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. /p h3Key Responsibilities: /h3 h3QMS gap assessment and improvement program /h3 ul liOwn 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. /li liTranslate 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. /li liDesign and redesign QMS processes, including the SOP lifecycle and document control process, and prepare the related design changes through QMS change control. /li liDefine 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. /li liIdentify opportunities to simplify, standardize or automate quality system processes, and verify that implemented improvements are effective. /li liProvide input to the quality manual, quality policy and quality objectives, and report the status of the improvement program as input to the management review. /li /ul h3eQMS replacement and validation /h3 ul liAct 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. /li liPlan 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. /li liCoordinate data migration and test execution, performed with the Quality Engineer, CAPA Process Improvement, and ensure completeness and data integrity of migrated documents and records. /li liSupport go-live together with the key users from each function. /li liAfter 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. /li /ul h3Internal audits and external audit readiness /h3 ul liAct 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. /li liEnsure ongoing readiness of the quality system processes, documentation and records for external audits and inspections (e.g., notified body, MDSAP auditing organization, FDA, Swissmedic). /li liSupport external audits and inspections, in which the Director, Quality Management leads the front room and the Manager, Quality Systems leads the back room. /li liPrepare responses to quality system audit findings and follow up the resulting actions within committed timelines. /li /ul h3QMS standards impact assessment /h3 ul liAssess 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. /li liDefine the resulting QMS changes for implementation by the Manager, Quality Systems, and share relevant updates with affected process owners. /li liMaintain up-to-date knowledge of quality standards and regulations applicable to medical devices, OTC drug products and cosmetics. /li /ul h3Required Qualifications Experience /h3 h3Must have /h3 ul liDegree in Life Sciences, Engineering, Quality Management or a related field. /li li3 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. /li liCurrent or most recent position at specialist or engineer level (e.g., QMS Specialist, Quality Systems Engineer, QA Engineer), doing quality systems work personally. /li liPractical 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. /li liHands-on experience with an eQMS platform (e.g., document control, change management, CAPA, audit and training modules). /li liExperience in computer system validation (e.g., ISO 13485 clause 4.1.6, GAMP 5, 21 CFR Part 11), including writing and executing validation protocols. /li liHands-on experience conducting internal audits in a medical device QMS. /li liFluent in English (written and spoken). /li /ul h3Nice to have /h3 ul liLead auditor certification (ISO 13485 or MDSAP). /li liExperience supporting the rollout of a new eQMS, including data migration. /li liAdditional experience with GMP for OTC drug products (21 CFR 211) or cosmetics (ISO 22716), in addition to medical device experience. /li liExperience building reports or dashboards from quality system data (e.g., in Excel, Power BI or the eQMS's native reporting tools). /li liGerman or other European languages. /li liStrong 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 /li liStrong attention to detail and a structured approach to documentation and record-keeping, with ownership of the accuracy and completeness of work /li liClear and concise written and verbal communication, with strong listening skills and the ability to clarify requirements and expectations before proceeding /li liOpenness to feedback, with the ability to translate it into practical improvements and adapt working methods when needed /li liA diplomatic and collaborative approach to cross-functional work, with the ability to influence without direct authority and follow up effectively with process owners /li liProactive and able to work independently, while recognizing when to seek guidance, flag risks, or escalation issues /li liSound 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 /li liAn analytical mindset, with the ability to interpret quality data and translate it into meaningful metrics and actionable insights /li liAdaptability to changing priorities and business or regulatory requirements, while maintaining quality and a continuous improvement mindset /li /ul h3Your Personality: /h3 pYou 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. /p