Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead the development and implementation of Quality Management Systems in accordance with applicable medical device and IVD regulations and standards, including ISO 13485, FDA QMSR (21 CFR Part 820), and ISO 14971
• Independently manage client projects, primarily on-site at customer locations, providing expert support for Quality Management System design, implementation, and maintenance
• Assess, review, optimise, and remediate existing Quality Management Systems to improve compliance, efficiency, and effectiveness
• Analyse quality and compliance challenges and develop practical, risk-based solutions that balance regulatory requirements with business needs
• Serve as a trusted advisor to clients, providing expert guidance and influencing stakeholders through indirect leadership and strong consultancy skills

Your Skills & Experience

• Master’s degree in Engineering, Natural Sciences, Biomedical Engineering, Materials Science, Pharmaceutical Sciences, or a related discipline
• Minimum of 10 years’ experience within the medical device, IVD, pharmaceutical, or another GMP-regulated industry
• At least 10 years of hands-on experience in the implementation, maintenance, and optimisation of Quality Management Systems compliant with ISO 13485 and/or FDA QMSR (21 CFR Part 820)
• Strong knowledge of medical device and IVD regulatory frameworks, quality requirements, and industry best practices
• Excellent analytical and systematic thinking skills, with a process-oriented and risk-based mindset
• Strong ability to work independently and prioritise effectively
• Outstanding documentation, presentation, stakeholder management, and interpersonal communication skills
• Fluency in English is a must, German language skills are highly desirable

Benefits

• Join an ambitious and dynamic consulting company in the Zurich area, specialising in the MedTech sector and known for its collaborative and positive working culture
• Benefit from flexible working arrangements in a diverse range of challenging and rewarding projects
• Work in an environment with a flat hierarchy, short decision-making paths, and a high degree of personal responsibility
• Enjoy a professional, supportive, and collegial atmosphere where teamwork and mutual respect are highly valued
• Take advantage of modern employment conditions, continuous learning opportunities, and professional development
• Receive a competitive compensation package complemented by attractive social benefits

To apply for this role, see our LinkedIn jobs page.

Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead global product development, lifecycle management, and continuous improvement projects in the medical device/pharma environment
• Translate product strategy into executable project plans together with cross-functional leadership
• Plan, execute, and monitor projects to ensure delivery of milestones, timelines, budgets, and quality objectives
• Coordinate cross-functional teams, external vendors, and global stakeholders throughout the project lifecycle
• Develop and maintain Design & Development Plans in compliance with regulatory requirements
• Proactively identify, assess, and mitigate project risks while managing scope, resources, and changes
• Apply project management best practices for planning, communication, governance, and decision-making
• Facilitate effective team collaboration, governance reviews, and stage-gate processes
• Maintain project documentation, dashboards, and knowledge management to ensure transparency and continuous improvement

Your Skills & Experience

• Bachelor’s or Master’s degree in Engineering or a related scientific or technical discipline
• 8–11 years’ professional experience, including at least 5 years within the medical device, pharmaceutical or biopharmaceutical industry
• Proven experience managing drug and/or medical device development and commercialization projects, preferably involving combination products
• Strong knowledge of project management methodologies and tools including Microsoft Project, Smartsheet, and Google Suite
• Solid understanding of 21 CFR 820.30 Design Control requirements
• Experience working with external suppliers and strategic development partners
• Ability to independently manage multiple complex projects in a fast-paced global environment
• Excellent communication, stakeholder management, and relationship-building skills
• PMP certification is considered an advantage
• Fluency in English is mandatory; German, Japanese or Danish is an advantage

Benefits

• Join an ambitious and dynamic consulting company in Basel, specialising in the MedTech sector and known for its collaborative and positive working culture
• Work in an environment with a flat hierarchy, short decision-making paths, and a high degree of personal responsibility
• Enjoy a professional, supportive, and collegial atmosphere where teamwork and mutual respect are highly valued
• Take advantage of modern employment conditions, continuous learning opportunities, and professional development
• Receive a competitive compensation package complemented by attractive social benefits
• This opportunity is a 1-year contract with a high likelihood of an extension

To apply for this role, see our LinkedIn jobs page.