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 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!