Quality System Manager

mylife Diabetes Care; Burgdorf; On-site; CHF 90,000 - 125,000; Full time

Job summary

mylife Diabetes Care in Switzerland is seeking a Quality Management/Quality Assurance professional to maintain and improve the Quality Management System and contribute to product QA activities on the market. You will work with colleagues across the business to keep processes clear, current and compliant with applicable requirements.

The role combines QMS and product-focused QA tasks, offering exposure to both quality systems and marketed products, with opportunities to influence audits,

Qualifications

• Initial experience in Quality Management or Quality Assurance is an advantage.
• Interest in quality systems and regulated processes.
• Experience with SAP, DMS, APM or TrackWise is an advantage.

Responsibilities

• 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.

Skills

Quality Management

Quality Assurance

Documentation

Organisational Skills

Collaborative Work Style

Education

Technical, medical or 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.

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