Quality Engineer (m/w/d) ISO 13485
Our client is an internationally active company with a strong reputation as a system supplier for the medical packaging industry. From design and film production to blister manufacturing, machine engineering, and full packaging services – everything comes from a single source.
Why This Role?
- Be part of a fast-evolving international MedTech environment where quality directly impacts healthcare outcomes.
- Take ownership of quality and regulatory processes and become a key player in ensuring compliance and continuous improvement.
- Collaborate across teams and with external partners – your input will make a visible difference.
- Join a company culture that values initiative, precision, and innovation – with room to grow professionally.
Your Key Responsibilities
- Lead quality management processes: audits, CAPAs, supplier qualification, risk management, and document control.
- Drive regulatory compliance, ensuring all standards (ISO 13485 and similar) are met.
- Implement quality objectives and help shape the future of the company’s ISO 13485 management system.
- Improve and develop processes to increase efficiency and maintain the highest industry standards.
- Train and support colleagues, promoting a strong culture of quality across the organization.
What You Bring
- A practical, solution-driven mindset with the motivation to take ownership and make things happen.
- 5+ years of experience in Quality Management under ISO 13485 or related standards.
- A solid technical background and ideally further training in quality management.
- Strong understanding of medical packaging regulations and industry standards.
- Analytical and problem-solving skills paired with a structured, precise working style.
- German fluent and English fluent.
- Experienced in MS Office and ERP systems.
What’s in It for You
- A responsible role with real impact in the MedTech industry.
- The chance to shape processes and influence company-wide quality standards.
- An international, innovative environment where your ideas are valued.
- A company culture that encourages ownership, collaboration, and continuous development.
Ref: JN-082025-832534