Occupation: Quality Systems Manager (m/w/d)
The SEI Group – SternMed GmbH, EndoMed Systems and Imed GmbH – is an established and fast-growing manufacturer of medical technology products based in Ravensburg, Germany. Our companies are committed to manufacturing and distributing a wide range of affordable German quality medical devices worldwide, while offering long-term commitment and local support. We are suppliers of products for diagnostic imaging (X-ray, ultrasound, MRI, CT), surgical solutions (operating tables and lights, anesthesia equipment, electrosurgical equipment) and patient care (patient monitors, ventilators, medical pumps) as well as endoscopy (rigid and flexible endoscopes).
We are looking for a motivated and committed person as Quality Systems Manager (m/f/d) with immediate effect. Become part of our team and actively contribute to ensuring the highest quality standards in our company.
Your tasks
- Create technical documentation in accordance with the requirements of MDR 2017/745 and help ensure that our products meet the highest standards
- Use your expertise to successfully apply the MDR (Medical Device Regulation) and the relevant medical device regulations to ensure the quality of our products
- Support us in further designing and developing our quality management system to drive continuous improvement and innovation
- You will be involved in the registration of our products outside the EU and thus contribute to expanding our international market share
- Assist us with internal and external audits to ensure compliance with standards and demonstrate our commitment to quality and safety
Your profile
- You have completed training or a degree in the relevant field and ideally have professional experience or further regulatory training in the field of medical devices or regulatory affairs
- Knowledge of the legal and normative requirements for the medical device industry in the EU and other countries is an advantage
- Experience in the area of quality management systems for medical devices is a plus
- You communicate confidently in German and/or English, both orally and in writing
- Your organizational skills help you to maintain an overview even in challenging situations
- You are characterized by diligence, reliability and the ability to concentrate and are the basis of your work
- You work independently and actively contribute your ideas
- Confident use of MS Office applications is a matter of course for you; knowledge of eQMS, Dynamics Nav or Risk Manager is an advantage
We offer
EndoMed Systems GmbH offers you a positive and familiar working atmosphere as well as the opportunity to contribute your skills to our passionate, multicultural team. A pleasant working environment at a high technical level, characterized by the diversity of our employees, their skills and approaches. We stand for an open and appreciative corporate culture with flat hierarchies and personal responsibility.
Type of employment:
- Full-time employment – on site
- Permanent employment contract
- 30 days vacation per year (with a 5-day week)
Benefits:
- Gifts: On birthdays and special occasions, we provide small surprises to show our appreciation and strengthen team spirit.
- Team building: We promote team spirit and cooperation through a variety of events and festive Christmas parties to create a positive working atmosphere.
- Further training opportunities: Benefit from training and further education to continuously expand your skills and knowledge.
- Competitive compensation: Receive a fair salary and attractive benefits such as a company pension plan that values your work.
- Refreshment: Enjoy free drinks such as water, coffee and tea to keep you refreshed while you work.
Have we aroused your interest?
Then we look forward to receiving your detailed application with details of your starting date and salary expectations! Please send your application via the form below or to the following email address:
Julia-Maria Enderle
hr@endomed.com
Candidates applying for this position should meet all the legal requirements to work in Germany. Visa sponsorship is not available at this time. Thank you for your understanding.