Quality System Manager

mylife Diabetes Care AG; Burgdorf; Hybrid; CHF 110,000 - 160,000; Full time

Benefits offered by this job

Pension fund

Mobility support

Free sport facilities

Family friendly

FlexWork

Job summary

mylife Diabetes Care AG in Burgdorf, Switzerland, is seeking a Quality System Manager to maintain and improve the Quality Management System and oversee QA activities for marketed products. The role combines QMS governance with product quality work across functions, providing variety and insight into our processes and devices.

You will act as a key user for SAP, DMS, APM and TrackWise, support audits, data analyses and documentation, and contribute to training and change control within a

Qualifications

• Quality management or quality assurance experience is preferred.
• Interest in quality systems and regulated processes in medical technology.
• Structured approach to documentation and follow-up.
• Fluent in English; German language is an advantage.

Responsibilities

• Review and approve quality changes to the management system.
• Maintain quality requirements and compliance within the management system.
• Act as a key user for SAP, DMS, APM and TrackWise.
• Support analyses, deviations and changes affecting the Quality Management System.
• Assist with audits and follow-up activities.
• Contribute to analysis, consolidation and reporting of quality data.
• Support document management, training, change control and QA for marketed products.

Skills

Fluent in English

German language skills

Structured documentation

Good organisational skills

Education

Technical/medical/scientific degree

Tools

SAP

DMS

APM

TrackWise

Job description

mylife Diabetes Care is a global medical technology company focused on integrated solutions for people with diabetes. As we continue to grow, we are developing the quality systems that support our products, processes and markets.
In this role, you will contribute to the maintenance and improvement of our Quality Management System and take on selected Quality Assurance activities related to products on the market. You will work with colleagues across the business to keep quality processes clear, current and aligned with applicable requirements. The combination of QMS and product-focused QA activities offers a varied role with insight into both our quality systems and the products we bring to market.

Quality System Manager | 100%

Ref. No. 382

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

• Support the review and approval of quality changes to the management system
• Help implement departmental objectives and maintain quality requirements and compliance within the management system, working with relevant functions and business areas
• Act as a key user for SAP, DMS, APM and TrackWise
• Support analyses, deviations and changes that affect the Quality Management System
• Assist with the preparation, conduct and follow-up of audits
• Contribute to the analysis, consolidation and reporting of quality data
• Support operational management system activities, including document management, training, change control, audit management, deviation management and quality improvement
• Help create and update quality documents and training materials when organisational, standards or regulatory changes affect the management system
• Support selected Quality Assurance activities related to products on the market, working with relevant teams on product quality topics

Your profile

• Technical, medical or scientific degree, or comparable vocational education
• Initial experience in Quality Management or Quality Assurance is an advantage
• Interest in quality systems, regulated processes and the medical technology environment
• Experience with SAP, DMS, APM or TrackWise is an advantage
• A structured approach to documentation and follow-up
• Good organisational skills and the ability to manage several tasks and priorities
• Confident communication and a collaborative working style
• 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

T [phone]
[e-mail]

mylife Diabetes Care AG
Lyssachstrasse 40
CH-3400 Burgdorf
Switzerland