QA Lead – APL & GEM EMEA | Quality Excellence

Alcon; Freiburg; On-site; CHF 120,000 - 180,000; Full time

Job summary

Alcon is seeking a Quality & Regulatory Affairs leader to oversee all QA activities at the country/cluster level. You will ensure compliance with ISO13485, GDP, and other regulatory requirements, acting as Qualified Person for APL and guiding continuous improvement across QA processes.

The role includes managing audits, CAPA, risk management, and collaboration with leadership to uphold high standards of quality and regulatory compliance for medical devices and pharmaceuticals.

Qualifications

• BSc degree in a scientific or engineering discipline.
• 5 years’ experience in the medical device or pharmaceutical industry.
• 3 years of QA management experience including comprehensive knowledge of ISO13485.

Responsibilities

• Act as Qualified Person for APL and maintain compliance with quality requirements.
• Lead QA activities and ensure regulatory and quality system compliance (ISO13485, GDP, MDR if applicable).
• Develop and execute strategies for continual quality oversight of APL and Representative Offices.
• Coordinate audits with Health Authorities and Notified Bodies and manage CAPAs and root-cause investigations.

Skills

QA management

Regulatory compliance

People management

Education

BSc in science or engineering

Job description

Alcon is seeking a Quality & Regulatory Affairs leader to oversee all QA activities at the country/cluster level. You will ensure compliance with ISO13485, GDP, and other regulatory requirements, acting as Qualified Person for APL and guiding continuous improvement across QA processes.

The role includes managing audits, CAPA, risk management, and collaboration with leadership to uphold high standards of quality and regulatory compliance for medical devices and pharmaceuticals.