Quality Assurance Manager

mylife Diabetes Care; Burgdorf; On-site; CHF 110,000 - 160,000; Full time

Job summary

mylife Diabetes Care is seeking a Quality Assurance Manager to oversee 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.

You will lead QA activities across projects, provide clear quality guidance, manage stakeholder expectations and support audits by internal,

Qualifications

• Several years of practical Quality Assurance experience in a regulated industry such as medical technology, pharmaceuticals or biopharmaceuticals.
• Strong knowledge of QA methods and relevant standards and regulations (ISO 13485, EU MDR, 21 CFR Part 820, GMP).
• Experience with design control, design changes or QA in product development.
• Experience supporting regulatory submissions is an advantage.

Responsibilities

• Coordinate quality assurance activities in design and development projects.
• Provide quality guidance on project and product compliance, design controls and design changes with cross-functional teams.
• Participate in risk assessments and support regulatory submissions by ensuring relevant quality requirements and documentation are addressed.
• Support 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 quality documentation and support compliance with internal, customer, industry and regulatory requirements.
• Coordinate stakeholder input and oversee open quality topics across projects and products.
• Provide professional quality leadership within projects and coordinate relevant stakeholders.
• Support quality improvements and contribute to audits with internal, customer and authorities.

Skills

Quality Assurance experience

Stakeholder management

Communication skills

Organisational skills

English proficient, German advantage

Education

Degree in a scientific or comparable discipline

Job description

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