Quality Assurance Manager in Burgdorf

mylife Diabetes Care is a global medical technology company focused on integrated solutions for people with diabetes. We develop products that support people in their daily lives, and quality is central to bringing those products to market and supporting them throughout their lifecycle.
As Quality Assurance Manager, you will focus on quality assurance in design and development projects and for products on the market. You will work closely with Development, Software, Risk Management, Regulatory Affairs and Product Care to coordinate project and product compliance, assess design changes and address quality issues. The role involves a broad range of stakeholders and requires you to keep oversight, set priorities and provide clear quality guidance.

Quality Assurance Manager | 100%

Ref. No. 381

Location: Burgdorf | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

Your main tasks

• Coordinate quality assurance activities in design and development projects
  
• Provide quality guidance on project and product compliance, design controls and design changes in collaboration with Development, Software, Risk Management, Regulatory Affairs and Product Care
  
• Participate in risk assessments and support regulatory submissions by ensuring relevant quality requirements and documentation are addressed
  
• Support the investigation and follow-up of product-related non-conformities, deviations and potential design weaknesses
  
• Contribute to complaint handling and Quality Progress Reviews, using market feedback to identify and coordinate appropriate quality actions
  
• Review relevant quality documentation and support compliance with applicable internal, customer, industry and regulatory requirements
  
• Coordinate stakeholder input, maintain oversight of open quality topics and prioritise requests across projects and products
  
• Provide professional quality leadership within projects, clarify expectations and coordinate the contribution of relevant stakeholders
  
• Support quality improvements and contribute to internal, customer and authority audits within your area of responsibility
  

Your profile

• University degree in a scientific or comparable discipline, or an equivalent combination of education and relevant experience
  
• Several years of practical Quality Assurance experience in a regulated industry, such as medical technology, pharmaceuticals or biopharmaceuticals
  
• Strong knowledge of quality assurance methods and relevant standards and regulations, such as ISO 13485, EU MDR, 21 CFR Part 820 and GMP
  
• Experience with design control, design changes or quality assurance in product development
  
• Experience supporting regulatory submissions is an advantage
  
• Strong stakeholder management skills and confidence coordinating cross-functional project teams
  
• Excellent communication skills, with the ability to provide clear quality guidance and manage differing priorities
  
• Strong organisational skills, attention to detail and a solution-oriented approach
  
• Fluent in English; is an advantage
  

Experience the benefits of working with us

Pension fund
mylife Diabetes Care 55% of the pension contributions

Mobility support
Charging stations, Swiss Half Fare Card, parking, close to public transport

Free sport facilities
affordable or free gyms

Family friendly
Financial contributions to childcare

Working hours
working time arrangements: Shiftwork, annual working hours, part-time

FlexWork
Work where and when you want (in Switzerland)

Up-to-date work environment
Modern offices and production rooms; staff restaurant and break areas

Together, we create solutions that improve lives.

At mylife Diabetes Care, we develop integrated solutions that people with diabetes can truly rely on.
We are a fast-growing, family-owned company headquarterd in Burgdorf (Switzerland) – built on 40 years of innovation and active internationally.
We bring together expertise, dedication and a clear mission: empowering people to gain more freedom through better control.
Everything we do is developed with purpose and designed with care.
Our core competence lies in automated insulin delivery (AID). With mylife , we provide a system that adapts to the individual needs and everyday lives of people with diabetes.

Contact

Talent Acquisition Partner

mylife Diabetes Care AG
Lyssachstrasse 40
CH-3400 Burgdorf
Switzerland