Senior Quality Engineer — MedTech QA Lead & Reg Strategist

Volpi AG; Dietikon; Sur place; CHF 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Vacation days

Remote work

Parking

Career growth

Global collaboration

Résumé du poste

Volpi Group in Dietikon, Switzerland, is expanding its Quality department and seeks a Senior Quality Engineer to lead QA initiatives across Development and Production of medical and diagnostics devices.

Required is a Master’s degree and 8+ years in regulated manufacturing; ISO 13485 knowledge is essential, with German and English fluency. The role offers international collaboration and opportunities for growth within an agile, global team.

Qualifications

• Master's degree in a scientific or technical discipline.
• Minimum of 8 years of experience in medical device or highly regulated manufacturing environments.
• Solid knowledge of ISO 13485; familiarity with EU In-Vitro Diagnostics regulations is a plus.

Responsabilités

• Lead QA and engineering initiatives across development and production of medical devices, ensuring ISO and internal Quality System compliance.
• Oversee non-conformances, CAPA, validations, and implement changes aligned with VOLPI policies and international regulations.
• Lead audits internal, external, customer, and supplier; drive safety, risk management, and surveillance activities.

Connaissances

Six Sigma

Lean principles

Leadership

Analytical thinking

Formation

Master's degree in scientific or technical discipline

Outils

Microsoft Office

Description du poste

Volpi Group in Dietikon, Switzerland, is expanding its Quality department and seeks a Senior Quality Engineer to lead QA initiatives across Development and Production of medical and diagnostics devices.

Required is a Master’s degree and 8+ years in regulated manufacturing; ISO 13485 knowledge is essential, with German and English fluency. The role offers international collaboration and opportunities for growth within an agile, global team.