Ready to take the lead in ensuring robust, compliant processes for life-changing medical devices?

Join a dynamic medical technology company where your expertise in process validation and qualification will help deliver safe, reliable products that improve patients’ lives around the world.

Your Key Responsibilities:

• Act as the process owner for local process validation and device qualification activities, ensuring full compliance with applicable regulations and standards (e.g., ISO 13485).

• Provide technical leadership for the Validation Specialists within the Quality Assurance team.

• Plan, execute, and document validation activities for production processes and equipment.

• Develop, review, and approve validation plans, protocols (IQ, OQ, PQ), and final reports.

• Oversee equipment and system qualifications, including preparation of all required documentation.

• Review and update production work instructions to align with validated processes.

• Support the CAPA process by contributing to root cause analysis and corrective actions.

• Drive process validations during the transfer from development to production, including the creation of test specifications and method validations.

• Perform process and product-related tests and trials in collaboration with interdisciplinary teams.

• Ensure all processes meet internal quality standards and regulatory requirements.

• Support internal and external audits and inspections by regulatory bodies.

Your Profile:

• Completed technical vocational training or a comparable qualification, ideally with a background in manufacturing, medical devices, or plastics engineering.

• At least 3 years of practical experience in process validation and qualification, preferably in the medical device or pharmaceutical industry.

• First leadership experience in a manufacturing environment — or motivated to step into a leadership role.

• Solid knowledge of relevant quality and regulatory standards (e.g., ISO 13485, GMP).

• Hands-on experience preparing and reviewing validation and qualification documents.

• Strong understanding of manufacturing processes and how to ensure their compliance and performance through structured systems and controls.

• Proven ability to identify issues, analyze root causes, and implement practical solutions.

• Collaborative mindset with excellent communication and teamwork skills.

• Solution-oriented, flexible, and comfortable working with digital tools and validation software.

• Fluent German and strong, practical English skills.

What’s On Offer:

• A stable, impactful role in a company that values quality and innovation.

• A competitive, above-market salary package.

• A supportive team environment and structured onboarding to help you succeed.

• Exciting career development opportunities in a key area for the company’s long-term growth.

• A modern, well-equipped office with flexible working hours and hybrid work options (up to 2 days per week).

• Open culture, flat hierarchies, and a leadership team that values your input.

• Opportunities to contribute ideas and shape processes independently.

• Professional and personal development through internal and external training programs.

• Regular company events, free parking, and more!

Would you like to learn more?

Apply directly or reach out to Hollie Dear at Adaptive Life Science for a confidential chat!