Projektmanager QM-System Medizintechnik (m/w/d)

About

As an internationally active, family-run company, we have been developing and manufacturing electrosurgical instruments for ENT, microsurgery, and neurosurgery for over five decades: with the highest quality standards and innovative strength. Around 200 employees work at our modern, climate-neutral company headquarters on solutions that improve clinical outcomes worldwide.

To strengthen our QM department, we are looking for a Project Manager QM System Medical Technology (m/f/d). In this role, you will independently develop processes, implement them in the company, and navigate confidently within medical technology regulations. You enjoy interdisciplinary work and contribute to strong collaboration with your positive, solution-oriented approach.

Responsibilities

• Responsibility for planning, implementation, and further development of the QM system according to DIN EN ISO 13485, MDR, and MDSAP
• Management of projects for the further development of paperless QM documentation (CAQ) and optimization of process descriptions through graphical workflows and structured process representations
• Control and organization of the CAPA process, including support of measures as QM pilot/project manager
• Identification, evaluation, and integration of new regulatory requirements in the QM environment
• Conducting internal and external audits as well as supporting authority and customer audits
• Consulting and supporting specialist departments in ensuring regulatory requirements and the continuous improvement of the QM system
• Interface management and close cooperation with development, product management, and regulatory affairs to ensure product conformity
• Participation in product development projects, especially in risk management files and technical documentation

Requirements

• Completed technical or scientific degree or a comparable qualification or a QM training such as Quality Manager or Quality Auditor
• Knowledge in the area of national and international approvals
• Experience with design and process validations, especially FMEA
• Good knowledge of relevant regulations and standards (MDSAP, Regulation (EU) 2017/745 (MDR), ISO 13485 + 14971)
• Fluent German and English language skills

We Offer

• Flexible working hours
• Company pension scheme
• Hansefit
• Sports activities/courses as part of our company health management, such as back school, business yoga, or Nordic walking
• JobRad
• JobRoller
• Charging stations for electric cars
• Secure bicycle garage with charging facilities for e-bikes via chip access
• Flat hierarchies and short decision-making processes
• An appreciative corporate culture
• Good public transport links, Emmendingen train station 15 minutes away on foot
• A family-like and collegial working environment
• Administration and production in a new, climate-neutral company headquarters with state-of-the-art equipment

Further Information

Please note: An unrestricted work permit valid from the start of employment is required for employment at Sutter Medizintechnik. Time-limited or content-limited permits (e.g., for working students or secondary employment) are not sufficient.