• Represent Quality Engineering in all Design Controls and Product Development related aspects
• Ensure the efficiency of Design Controls (Quality by Design) in product development, process development and product maintenance activities
• Ensure compliance with relevant medical device and cGMP standards and regulations
• Actively take part in and facilitate Product Development and Quality process improvement efforts
• Apply Quality Engineering principles and tools in a dynamic way to development projects
• Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes
• Team member in digitalization programs related to QMS and product lifecycle management (PLM)
• Support Risk Management activities and directs product development decisions by promoting a Risk-Based approach
• Collaborate with Subject Matter Experts to identify and trace critical-to-quality attributes (CTQs) through all product development phases and to establish the control strategy
• Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction.
• Promote Advanced Product Quality Planning (APQP) and Design For Six Sigma (DFSS)
• Ensure all functions adhere to SHL procedure’s requirements and standards during all development and manufacturing stages.

• Minimum of 5 years’ experience hands-on experience in product development from concept to launch within the Medical Device or Pharmaceutical industry
• Expert knowledge of Design Controls and Product Development processes, particularly for medical devices and/or combination products.
• Knowledge of ISO 13485, QSR 820, ISO 14971, IEC62366, IEC62304
• Experience in establishing processes, authoring procedures, and driving cross-functional collaboration
• Excellent communication and stakeholder management skills with a strong customer-oriented approach.
• Consensus-building abilities to negotiate project deliverables, risks, and priorities.
• Team player and self-starter capable of thriving in an international, cross-company environment.
• Solution-oriented mindset coupled with solid analytical and decision-making skills.
• Willingness to travel internationally (up to 5%).
• Fluent in written and spoken English.

• Fluent in written and spoken German.
• Bachelor’s degree in engineering, life science or related scientific discipline
• Training and practical application of quality engineering methodologies (e.g. APQP, DMAIC, Lean, Design for Six Sigma)
• Working knowledge of statistical analysis and related software.

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Please note: We do not accept applications from recruitment agencies for this position.