Quality Assurance Manager

mylife Diabetes Care AG; Burgdorf; Hybrid; CHF 130,000 - 170,000; Full time

Benefits offered by this job

Pension plan

Mobility support

Gym access

Childcare support

Flexible working

Hybrid work

Modern offices

Job summary

mylife Diabetes Care AG in Burgdorf is seeking a Quality Assurance Manager (100%). You will shape QA activities across design, development and market products, collaborating with Development, Software, Risk Management, Regulatory Affairs and Product Care to ensure compliance and quality throughout the lifecycle.

You will lead quality guidance, participate in risk assessments, support regulatory submissions, handle deviations and non-conformities, and drive continuous improvement with a

Qualifications

• University degree in a scientific discipline or equivalent experience.
• Several years of practical QA experience in regulated sectors such as medical tech or pharma.
• Strong knowledge of ISO 13485, EU MDR, 21 CFR Part 820 and GMP.
• Experience with design control and design changes in product development.
• Experience supporting regulatory submissions is a plus.
• Strong stakeholder management and cross-functional coordination.
• Excellent communication and ability to align priorities.
• Fluent in English; German is an advantage.

Responsibilities

• Coordinate QA activities in design and development projects.
• Provide QA 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.

Skills

QA experience in regulated industry

Quality assurance methods

Regulatory knowledge ISO 13485 EU MDR

Education

University degree in sciences

Job description

Quality Assurance Manager | 100%

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.

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; German 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 Loop, we provide a system that adapts to the individual needs and everyday lives of people with diabetes.

Contact

Alban Haliti

Talent Acquisition Partner

Ask a question

mylife Diabetes Care AG

Lyssachstrasse 40

CH-3400 Burgdorf

Switzerland

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