Quality Assurance Lead – Medical Device Design & Compliance

mylife Diabetes Care; Burgdorf; In loco; CHF 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

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,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality Assurance experience

Stakeholder management

Communication skills

Organisational skills

English proficient, German advantage

Formazione

Degree in a scientific or comparable discipline

Descrizione del lavoro

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,