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.
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
- 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
- Good written and spoken English; German is an advantage
#J-18808-Ljbffr
Quality Assurance Manager in Burgdorf Arbeitgeber: mylife Diabetes Care
Die TecMed Deutschland GmbH in Schwerin bietet eine herausragende Arbeitsumgebung für IT-Profis, die an der Gestaltung innovativer Medizintechnik mitwirken möchten. Mit flexiblen Arbeitszeiten, einem attraktiven Gehaltspaket und individuellen Entwicklungsmöglichkeiten fördert das Unternehmen eine offene und unterstützende Kultur, in der Teamarbeit und persönliche Entfaltung im Vordergrund stehen. Zudem ermöglicht die enge Zusammenarbeit mit dem Management und die Verantwortung für eigene Projekte eine sinnstiftende Karriere in einem zukunftsorientierten Umfeld.
