Description

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.