- You will take on the leadership and management of the Quality Management department and be responsible for maintaining and strategically developing the ISO 13485 and MDSAP certified quality management system.
- You ensure that the QM system meets the regulatory requirements necessary for approvals in Europe, the USA, Canada, and other markets.
- Close interdisciplinary collaboration with all departments regarding quality management
- Technical and disciplinary leadership as well as further development of the Quality Management department
- Creating and optimizing workflows and processes within the Quality Management department
- Establishing personnel development for the entrusted team
- Creation of QM-related documents, records, and statistics
- Responsibility for ECM-supported document control
- Planning and execution of internal and external audits
- Communication with and point of contact for the Notified Body regarding all questions of collaboration, the QM system, and external audits
- Preparation, coordination, and moderation of the Management Review
- Creation of quality planning relevant to the company
- Participation in CAPA management and permanent member of the CAPA committees
- Participation in process management and permanent member of process change projects
- Supporting development projects, including conducting milestone reviews
- Responsibility and support for various technical topics within the department (e.g., validation, equipment management, biological evaluation)
Head of Quality Management (m/f/d)
Heidelberg Engineering GmbH • Heidelberg
-
Full-time
Heidelberg
from today
Your responsibilities
Your qualifications
- Completed training or completed technical/scientific studies
- Several years of professional experience in setting up and expanding QM systems at a medical device manufacturer with products in risk class IIa/b
- Qualification as quality manager or quality auditor
- Qualification as validation officer
- Audit experience (internal and supplier)
- Experience in CAPA management, regulatory affairs and process management
- Lean Six Sigma Yellow Belt qualification or higher
- Very good MS Office skills (Word, Excel, PowerPoint, Visio)
- Good written and spoken German and English skills
Your profile
- High sense of quality and responsibility
- Strong interpersonal skills as well as good communication skills and a confident manner
- Ability to work in a team and strong negotiation skills
- Solution-oriented and accurate way of working
- Goal- and action-oriented working style
- Strong hands-on mentality
- Analytical skills
We offer
- Remote work options to support work-life balance
- Flexible working hours based on trust
- Attractive location in Heidelberg with connections to the main train station and highway
- Subsidized job ticket
- Company bike for private use through a bike leasing program
- Parking spaces and bicycle storage
- Fitness subsidy for Pfitzenmeier, Venice Beach, FitBase, and Urban Sports Club
- Attractive, performance-based compensation
- Professional development and training opportunities, including access to a digital learning platform
- Company pension scheme
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?
