- Development of QM processes and creation of QM documentation and process documentation
- QM support and monitoring of development projects and processes
- Creation and review of technical documentation
- Preparation of documentation for biological evaluation and coordination of activities with laboratories
- Coordination of validation activities of the service provider for EO sterilization of disposable components
- Supervision of the topic "Reprocessing of medical devices" and development and preparation of requirements documentation
- Implementation and documentation of internal quality audits
- Participation in CAPA management and monitoring of the implementation of measures
- Participation in or implementation of various projects in the area of quality management
Quality Manager (m/f/d) Medical Technology
Heidelberg Engineering GmbH • Heidelberg
-
Full-time
Heidelberg
from today
Your responsibilities
Your qualifications
- Successfully completed studies in the field of medical technology with a focus on biotechnology or a comparable qualification
- Qualifications in the field of quality management, preferably on the basis of ISO 13485
- Knowledge of the regulations for medical devices in Europe (EU MDR), the USA, as well as other markets is an advantage
- Knowledge of the standards ISO 10993-1 (family of standards), ISO 17664 and ISO 11135 is an advantage
- Several years of experience in the above mentioned tasks
Your profile
- Fluent German and very good English skills, both written and spoken
- Very good organizational and administrative skills
- High sense of quality and responsibility
- A high degree of initiative and flexibility
- Good analytical skills and a solution-oriented working style
- Ability to work in a team and good communication skills
We offer
- Possibilities for mobile working in order to achieve a work-life balance
- Flexible working hours on a basis of trust
- Company bicycle for private use as part of a bike leasing offer
- Fitness allowance for Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club
- Attractive, performance-oriented compensation
- Continuing education and training opportunities as well as a digital learning platform
- Cost subsidy for job ticket
- Company pension plan
- Weekly fruit basket and free drinks such as water, coffee and tea on site
- Parking facilities and bicycle storage
- Presents for company anniversaries
- Regular employee events
- Variety of discounts for online shopping through corporate benefits
It's that easy to apply!
- Step 1: Your online application
- Simply click on “Apply” and fill out the short application from. This only takes less than three minutes and can also be done on your mobile phone.
- Step 2: First Interview
- We will get back to you as soon as possible. If there is a fit, we will invite you to a first online interview.
- Step 3: In-person interview
- If the first meeting went well, we will invite you to another meeting in the office.
- Step 4: It's a match? Welcome to Heidelberg Engineering!
- You get all documents and information you need for your start and onboarding. We look forward to having you in our Team soon!
Our benefits
Employee jubilees:
To show our appreciation, we reward our longstanding employees for company anniversaries and retirements.
Bike leasing:
Whether e-bike or city bike – we offer a bike leasing opportunity to support the health of our employees and to contribute to CO2 neutrality.
Company pension scheme:
We support you in your retirement plans so that you can look forward to the future.
Employee events:
Summer and Winter events, team events or simple after-work get-togethers contribute to a supportive and collaborative culture.
Family business:
Our corporate culture can be described as international environment with a family-like working atmosphere in which you can contribute with your individual skills.
Feedback interviews:
We consider a constructive, reciprocal, and continuous feedback culture as essential for your further development and career planning.
Healthy snacks and hydration:
A weekly delivery of fresh fruits, as well as free water, tea and coffee on site provide you with a good start into the day and boost your energy.
Job ticket:
We support you with our subsidized job/Germany ticket and thereby promote an ecological alternative.
Mobile working:
We offer mobile working options for a better work-life integration and flexibility.
Modern work conditions:
We offer flexible working hours on a trust basis, 30 days of annual leave (based on a 5-day week) and additional leave days for special occasions.
Onboarding process:
Heidelberg Engineering provides you with an individual training plan for your successful onboarding.
Parking opportunities:
Whether by bike, scooter or car – we offer opportunities for parking spaces as well as a separate room to store your bike.
Stay fit:
You can join Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club with our fitness subsidy. With a wide range of gyms, classes and locations, there are plenty of opportunities for you to enjoy.
Top location:
Our attractive location in Heidelberg with direct access to the freeway, public transport and Heidelberg's main railway station make your journey both faster and less complicated.
Training and development opportunities:
Lifelong learning and continuous professional development are among the success factors in the dynamic environment in which we operate. That's why we offer a digital learning platform to expand your professional, social, methodological, and personal skillset.
Corporate Benefits:
Via our free access to our own Corporate Benefits platform we provide several discount codes for our employees with over 800 different brands in various categories such as travelling, fashion, technology, food, mobility, finance, leisure activities and many more.
Do you have any questions?
We are looking forward to supporting you!
Feel free to contact our HR Team. E-Mail copied! Copy E-Mail?
