Are you ready to shape the quality of life-changing medical devices right from the idea stage through to market launch?
Join a leading medical technology company and take ownership for ensuring that new product developments meet the highest quality standards - from early design concepts to production and beyond.
Your Key Responsibilities:
Act as a Quality Assurance representative in cross-functional development teams, making sure all projects comply with relevant design control processes, risk management activities, and technical standards.
Review and approve all design and development documentation, ensuring completeness and compliance with regulatory and internal quality requirements.
Advise and train project teams on best practices for document management and good documentation principles (GDP).
Provide QA guidance for technical development, risk management, and human factors activities — from initial feasibility through to design transfer and industrialization.
Support internal and external innovation projects with quality-related expertise and build strong links with production quality teams for topics like process validation and test method validation.
Champion the implementation of Quality by Design principles, helping define robust control strategies during development.
Drive and oversee change and deviation management during development projects and product lifecycle phases.
Lead or participate in Design Reviews for new product development and sustaining engineering.
Support Change Control activities by approving change plans and providing QA input throughout.
Your Profile:
Bachelor’s, Master’s, or Diploma degree in Medical Devices, Biology, Chemistry, or Engineering (mechanical, chemical, or biomedical).
Strong knowledge of quality system standards and medical device regulations (ISO 13485, 21 CFR 820, MDR).
Familiarity with international regulatory frameworks such as MDD, MDR, or IVDR.
Basic understanding of Human Factors Engineering (IEC 62366) and Risk Management (ISO 14971).
Practical experience with the development, industrialization, or lifecycle management of medical devices.
Hands-on experience in quality assurance and control.
Proficient in German and English, both written and spoken.
Skilled in MS Office and comfortable working with digital documentation tools.
Your Strengths:
Strong communicator who thrives working with international teams and partners.
Proactive, self-organized, and results-oriented approach.
Confident and assertive, yet collaborative — able to moderate discussions and drive decisions when needed.
Flexible mindset with a commitment to delivering high-quality results.
Willingness to travel as needed.
What’s On Offer:
A secure and meaningful role in an innovative company dedicated to patient safety and product quality.
An open, supportive culture and a structured onboarding process.
Friendly teams, flat hierarchies, and a culture that values your ideas.
Flexibility through modern working time models and up to 2 days remote per week.
Opportunities for professional and personal growth through targeted training.
Free parking, regular team events, and much more!
Curious to explore this opportunity?
Apply directly or reach out to Hollie Dear at Adaptive Life Science for a confidential chat about this position.