Senior QMS Implementation PM - MedTech/IVD, Flexible Work

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

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