Quality Manager (m/f/d)

MedicalCommunications GmbH • Heidelberg

  • Full-time


from today

Your responsibilities

  • Further development, maintenance and upkeep of the quality management system in accordance with the applicable requirements, e.g. ISO 13485, ISO 9001 and taking into account the standards IEC 62304, ISO 14971, IEC 62366
  • Preparation, implementation and monitoring as well as follow-up of 1st party, 2nd and 3rd party audits
  • Analysis of processes, further development and creation of procedures
  • Contact person for external partners such as authorities and notified bodies
  • Operational preparation, provision and distribution of approval documents for worldwide approval
  • Standards and specification management
  • Participation in risk management
  • Maintenance and expansion of the company's own documentation systems
  • Preparation and processing of reports/evaluations
  • Support in the validation of software products
  • Support in the creation and maintenance of technical documentation
  • Know and understand relevant national and international regulations (laws, ordinances, guidelines, standards) and be able to assess the conformity of documentation with these regulations.
  • Know and understand the manufacturer's products (medical context, physical principle, technical design)

Your qualifications

  • Successfully completed scientific training or a comparable qualification
  • Experience in the medical device environment
  • Knowledge of GAMP as well as project, quality and document management
  • Confident handling of MS Office, Share Point and workflow systems
  • Knowledge of relevant regulatory requirements, especially GAMP, DIN EN ISO 13485, Quality System Regulations (FDA)
  • Experience in project management
  • Very good knowledge of German and English, both written and spoken

Your profile

  • Didactic skills to communicate regulatory requirements
  • Strong communication and assertiveness skills
  • Precise, structured and pragmatic way of working
  • Ability to work in a team and high level of initiative

We offer

  • Interesting and challenging tasks in an international, dynamic company 
  • Open corporate culture and very good working atmosphere 
  • Possibility of mobile working
  • Modern equipped workplaces 
  • Performance-related remuneration
  • A highly motivated team in an international environment 
  • Attractive location in Heidelberg in the Bahnstadt incl. job ticket

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!
Apply now

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!