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!