Department Head Quality Management (m/w/d)

We are Opto GmbH: as a provider of professional solutions for industrial microscopy, camera technology, and software with a focus on photonics and image processing, we have been offering quality that has convinced customers all over the world for over 45 years. Our products are in demand in biotechnology, medical technology, science, and industry.

As future department head of quality management, you will initially work actively in the existing QM team (2 people) with us. In this phase, you will learn our processes, products, and corporate culture in detail. Then, you will gradually take over the professional and disciplinary responsibility for the department (1 person).

Your guiding principle is always:

Regulatory and normative requirements are fulfilled with a focus on minimizing resource expenditure while achieving maximum, sustainable benefits for the company.

Tasks

• Active participation in quality management and gradual takeover of department leadership including personnel responsibility
• Development and optimization of our existing quality management system according to ISO 9001
• Orienting key processes to the requirements of ISO 13485 (without current certification intention)
• Interpretation and application of standards, regulations, and guidelines with a focus on their core content and benefits for our company
• Identification, evaluation, introduction, and further development of suitable software solutions and digital tools to efficiently support quality management
• Ensuring objective evaluation criteria to achieve the best possible outcome – not the easiest way
• Ongoing improvement of processes, structures, and documentation
• Collaboration with adjacent departments and support for quality-related questions

Qualification

• Multiple years of professional experience in quality management, ideally in regulated environments
• Very good knowledge of ISO 9001 and a solid understanding of ISO 13485
• A high ability to pragmatically, flexibly, and need-oriented implement normative requirements
• An open, reflective personality with the courage to question existing approaches and develop better solutions
• A structured, analytical, and solution-oriented working style
• A willingness to take responsibility and further develop a small team both professionally and personally
• A high standard for quality, effectiveness, and sustainability of solutions

Benefits

• The opportunity to actively shape and further develop quality management
• A large scope for selecting and introducing methods and tools
• A gradual transition into a leadership position with a clear perspective
• Short decision-making paths and an environment where meaningful improvements are explicitly desired
• Collaboration in a small, committed team with high professional proximity to the company
• Company pension scheme
• Flexible working hours within our core working hours
• Individual onboarding

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