Quality Assurance Engineer (m/f/d)

About the job

Quality Assurance Engineer (m/f/d)

Challenge The Future With Us - Join Our Global Team

H&T Presspart is part of the Heitkamp & Thumann Group. At more than 20 locations in 9 countries, over 1,700 employees work for the family-owned corporate group. H&T Presspart is the market leader in the manufacture of components and pharmaceutical devices for the administration of medicines for the treatment of respiratory diseases. With more than 50 years of experience and a broad range of products and services, H&T Presspart is the preferred partner of the pharmaceutical industry.

To strengthen our team, we are looking for a dynamic and experienced individual as a Quality Assurance Engineer (m/f/d).

Your Responsibilities

• Quality Planning & Process Development: Develop quality plans for new products together with development, process engineering and production, and continuously improve existing processes within the framework of continuous improvement process (CIP).
• Data-Based Quality Assurance: Monitor production process data using statistical methods, detect trends early and initiate preventive measures.
• Testing, Measurement & Monitoring Systems: Further develop measurement methods, MSA as well as modern vision and AI-supported testing and measurement systems; ensure cleanroom monitoring.
• Project & Change Management: Accompany engineering projects in all phases from a quality perspective, coordinate change control activities and ensure timely implementation.
• Deviation & Cause Management: Handle product-related non-conformities, complaints, SCARs and CAPAs as well as conduct structured root cause analyses.
• Interfaces & Operational Quality: Support production and QA/QM in daily business and collaborate on quality-relevant topics with customers, suppliers and internal departments.

Your Profile

• Technical training or degree, e.g. mechanical engineering, production engineering, process engineering or medical technology, or a comparable qualification.
• Experience in quality management or quality assurance in a regulated production environment, ideally pharmaceutical or medical technology.
• Good knowledge of statistical methods, SPC and MSA; experience with validation is an advantage.
• Practical experience in CIP, change control and root cause methods such as 5 Why, Ishikawa or Kepner-Tregoe.
• Interest in modern testing and measurement systems; experience with vision or AI-supported applications is a plus.
• Open, curious and team-oriented personality with a structured way of working, willingness to shape as well as very good German and good English skills.

We Offer

• At least 25 days of holiday per year
• We cover 100% of the employee contribution for non-occupational accident and daily sickness allowance insurance
• Holiday pay
• Flexible working time models depending on function and task
• The company location is easily accessible by public transport and car
• Free parking spaces
• Company loyalty is rewarded with a long-service gift

How to Apply

We look forward to receiving your application! Please use our online application tool to send us your documents. Become part of our team and help shape the future of the pharmaceutical industry with us.