Project Manager QMS Implementation Medical Device / IVD (m/f/d, 100%)

Congenius AG; Zürich; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Congenius AG is seeking an experienced Project Manager QMS Implementation to support clients in the medical device and IVD industries. You will lead the development, implementation, optimisation, and remediation of Quality Management Systems (QMS), ensuring compliance with global regulatory requirements while supporting business objectives.

Based in the Zurich area, you will manage client projects on-site, provide expert guidance, and balance regulatory needs with business goals using a

Qualifikationen

• Master's degree in Engineering or related discipline.
• Minimum of 10 years in GMP-regulated medical device/IVD/pharma industries.
• 10+ years in implementation, maintenance, and optimisation of QMS with ISO 13485 and/or FDA QMSR.
• Strong knowledge of medical device and IVD regulatory frameworks and best practices.
• Excellent analytical, process-oriented, risk-based mindset.
• Excellent written and verbal communication skills.

Aufgaben

• Lead development and implementation of QMS per ISO 13485, FDA QMSR (21 CFR Part 820), and ISO 14971.
• Independently manage client projects, primarily on-site at customer locations.
• Assess, review, optimise, and remediate existing QMS to improve compliance and efficiency.
• Analyse quality and compliance challenges and develop practical, risk-based solutions.
• Serve as a trusted advisor with strong consultancy and stakeholder management skills.

Kenntnisse

QMS implementation

Quality management

Regulatory knowledge

Project leadership

Stakeholder management

Analytical thinking

Documentation

Presentation

On-site work

Independent work

English fluency

German desirable

Ausbildung

Master's degree in Engineering

Jobbeschreibung

Project Manager QMS Implementation Medical Device / IVD (m/f/d, 100%)

About the Role

Congenius AG is seeking an experienced Project Manager QMS Implementation to support our clients in the medical device and in vitro diagnostics (IVD) industries. In this role, you will lead the development, implementation, optimisation, and remediation of Quality Management Systems (QMS), ensuring compliance with global regulatory requirements while supporting business objectives.

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 and Experience

• Master's degree in Engineering, Natural Sciences, Biomedical Engineering, Materials Science, Pharmaceutical Sciences, or a related discipline
• Minimum of 10 years of 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, prioritise effectively
• Outstanding documentation, presentation, stakeholder management, and interpersonal communication skills
• Fluent in English; German language skills are highly desirable
• Join an ambitious and dynamic consulting company in the Zurich area, specialising in the medical technology sector and known for its collaborative and positive working culture
• Benefit from flexible working arrangements and a diverse range of challenging and rewarding projects
• Work in an environment with flat hierarchies, 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

Who we are

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.