Senior Quality Engineer

h3Volpi Group /h3pWe drive innovations for next-generation instrumentation in the human diagnostics and life sciences industry. Fortune 500 companies rely on our development and manufacturing of optoelectronic systems tailored to their applications. With our sites in Dietikon (Zürich), Switzerland and Auburn (NY), USA, we work closely with our customers and provide a broad range of services of excellent quality. /ppWe are expanding our bQuality /b department and hiring for our Dietikon location a bSenior Quality Engineer /b /ph3Key responsibilities: /h3ulliLead quality assurance and engineering initiatives across Development and Production of components for medical and diagnostics devices, ensuring compliance with ISO and internal Quality System requirements, including review and approval of design and lifecycle management activities. /liliOversee process- or product-specific non-conformances, CAPA, validations, and plan and implement changes ensuring alignment with VOLPI Global policies and international regulations. /liliDrive and support internal, external, customer, and supplier audits. /liliLead Safety, Risk Management, and Surveillance activities, including complex customer complaint investigations and reporting. /liliShape and implement regulatory strategies across the company. /liliDevelop, harmonize, and update Quality Management System procedures across US and European operations. /liliConduct advanced data analysis using statistical methods to support continuous improvement and strategic decision-making. /li /ulh3Qualifications: /h3ulliMaster's degree in scientific or technical discipline. /liliMinimum of 8 years of experience in the medical device industry or another highly regulated manufacturing environment. /liliExpertise in Six Sigma, Lean principles, and related methodologies desirable. /liliProven experience with QMS, validation and verification processes, risk management, and complex failure investigations. /liliStrong analytical and strategic problem-solving skills, able to synthesize complex information for effective solutions. /liliExceptional interpersonal, leadership, communication, and organizational skills; able to manage multiple projects and priorities effectively. /liliSolid knowledge of ISO 13485; familiarity EU In-Vitro Diagnostics regulations is preferred. /liliPrior audit experience and exposure to manufacturing or RD environments is a plus. /li liProficient in Microsoft Office applications. /li liWillingness to travel internationally to sites, customers, and suppliers (approx. 2 per year %). /li liBusiness-fluent in English and German (B2 level). /li libThe right attitude: a hands-on, pragmatic, and solution-oriented mindset, with curiosity, openness, and the ability to collaborate effectively across teams and cultures. /b /li /ulh3Our Offer: /h3ullicompetitive total compensation /lilienjoy 27 vacation days (22 days 5 bridging days) /liliopportunity to work remotely one day per week /lilicomplimentary parking spaces provided /li liexperience a flat organizational structure /lilicollaboration with our team in the United States /lilitake advantage of quick decision-making processes, long-term career opportunities, and personalized professional development /li listep into a role that offers independence, variety, and the potential for growth within a dynamic, international setting /liliwork in a contemporary office building featuring a rooftop terrace, conveniently located near the Dietikon train station /liliparticipate in regular social and professional events with colleagues /lilijoin a highly motivated, friendly team and enjoy attractive employment terms /li /ul #J-18808-Ljbffr