Quality Assurance Lead

Volpi Group

We 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.

We are expanding our Quality department and hiring for our Dietikon location a Quality Assurance Lead

Key responsibilities:

• Lead 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.
• Oversee process- or product-specific non-conformances, CAPA, validations, and plan and implement changes ensuring alignment with VOLPI Global policies and international regulations.
• Drive and support internal, external, customer, and supplier audits.
• Lead Safety, Risk Management, and Surveillance activities, including complex customer complaint investigations and reporting.
• Shape and implement regulatory strategies across the company.
• Develop, harmonize, and update Quality Management System procedures across US and European operations.
• Conduct advanced data analysis using statistical methods to support continuous improvement and strategic decision-making.

Qualifications:

• Master’s degree in scientific or technical discipline.
• Minimum of 8 years of experience in the medical device industry or another highly regulated manufacturing environment.
• Expertise in Six Sigma, Lean principles, and related methodologies desirable.
• Proven experience with QMS, validation and verification processes, risk management, and complex failure investigations.
• Strong analytical and strategic problem-solving skills, able to synthesize complex information for effective solutions.
• Exceptional interpersonal, leadership, communication, and organizational skills; able to manage multiple projects and priorities effectively.
• Solid knowledge of ISO 13485; familiarity EU In-Vitro Diagnostics regulations is preferred.
• Prior audit experience and exposure to manufacturing or R&D environments is a plus.
• Proficient in Microsoft Office applications.
• Willingness to travel internationally to sites, customers, and suppliers (approx. 2 per year %).
• Business-fluent in English and German (B2 level).
• The right attitude: a hands-on, pragmatic, and solution-oriented mindset, with curiosity, openness, and the ability to collaborate effectively across teams and cultures.

Our Offer:

• competitive total compensation
• enjoy 27 vacation days (22 days & 5 bridging days)
• opportunity to work remotely one day per week
• complimentary parking spaces provided
• experience a flat organizational structure
• collaboration with our team in the United States
• take advantage of quick decision-making processes, long-term career opportunities, and personalized professional development
• step into a role that offers independence, variety, and the potential for growth within a dynamic, international setting
• work in a contemporary office building featuring a rooftop terrace, conveniently located near the Dietikon train station
• participate in regular social and professional events with colleagues
• join a highly motivated, friendly team and enjoy attractive employment terms

Important notice:

We do not accept unsolicited CVs from recruitment agencies. Any CVs sent without a prior written agreement will be considered unsolicited, and we reserve the right to process them without incurring any agency fees.