Supplier Quality Engineer (m/f/d)

Heidelberg Engineering GmbH • Heidelberg

Full-time

Heidelberg

from today

Your responsibilities

Planning, conducting, and following up on supplier audits (process and system audits), including the preparation of detailed audit reports and consistent monitoring of corrective actions until completion
Qualification and ongoing monitoring of suppliers, as well as the establishment and maintenance of the supplier management system (supplier selection, evaluation, and classification)
Development, optimization, and documentation of QM processes with a focus on supplier management and supplier complaint handling (including complaint processing, 8D reports, and SCAR processes)
Creation and maintenance of quality documentation (quality agreements, supplier specifications, test plans, quality plans)
QM-related guidance and support for development projects at suppliers (design transfer, process validation, first article inspection / FAI / PPAP-like processes)
Support for maintenance and change projects (change management) at the supplier level
Technical support in resolving quality nonconformities and technical issues with product components in close coordination with development, manufacturing, and suppliers
Participation in CAPA management (particularly supplier-related nonconformities) and monitoring the effectiveness of implemented corrective actions
Support in the creation and updating of production risk assessments (pFMEA) and supplier-related quality plans
Planning, coordination, and QM support for process and product validations (IQ/OQ/PQ)—with a clear focus on supplier processes
Preparation and evaluation of QM-relevant statistics, key performance indicators, and trend analyses (supplier performance, complaint rate, audit follow-up, etc.)
Close collaboration with internal departments (Purchasing, Development, Production, Regulatory Affairs) as well as with external suppliers and, where applicable, Notified Bodies

Your profile

A completed degree in a technical or scientific field (Bachelor’s or Master’s), e.g., in mechanical engineering, electrical engineering, medical technology, biomedical engineering, industrial engineering, quality management, or a comparable field
Several years of professional experience in quality management / supplier quality—preferably in medical technology, pharmaceuticals, or other highly regulated industries
Demonstrable auditing experience in accordance with ISO 9001 and ISO 13485 (ideally as a lead auditor or with relevant training/certification)
Very good understanding of quality methods and tools: 8D, 5-Why, Ishikawa, (P)FMEA, SPC, process validation (IQ/OQ/PQ), Gage R&R, CAPA, complaint management
Proficiency in handling QM documentation and regulatory requirements (ISO 13485, ISO 9001, 21 CFR Part 820 if applicable, MDR/IVDR, ISO 14971)
Basic knowledge of statistics (e.g., process capability, hypothesis testing, trend analysis, SPC) and experience with statistical analysis
Knowledge of Lean Management is a plus (e.g., 5S, Kaizen, waste reduction, continuous improvement)
Excellent written and spoken German and English
Strong communication and teamwork skills, with a confident demeanor when interacting with internal and external stakeholders
Analytical, structured, and solution-oriented approach to work
Willingness to travel (domestic/international) approximately 20–40% depending on project and audit schedules

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!

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?

Feel free to contact our HR Team. E-Mail copied! Copy E-Mail?

Could we convince you?