EMEA QA Senior Manager – APL & GEM

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

Job summary

Alcon is seeking a Quality & Regulatory Affairs professional in Switzerland to lead all quality activities at the country level and ensure compliance with ISO 13485, EU MDR (as applicable) and GDP requirements. The role drives continual improvement of quality oversight for APL and the Representative Offices.

You will promote a strong quality culture, mentor QA staff, perform QMS oversight as the Quality Management Representative, coordinate audits, CAPA, supplier qualifications and regulatory

Qualifications

• BSc degree in a scientific or engineering field.
• 5 years' experience in the medical device or pharmaceutical industry.
• 3 years of QA management experience with ISO13485 knowledge.
• Experience with GDP/audit processes is a plus.

Responsibilities

• Promote a Quality Culture across the affiliate and leadership teams.
• Lead QA personnel through training and effective communication.
• Act as Quality Management Representative ensuring QMS compliance and maintenance.
• Oversee CAPA, audits, supplier qualifications and regulatory activities.

Skills

Quality Management

Regulatory Compliance

Leadership

QA Training

Education

BSc in Science/Engineering

Tools

ISO 13485 Knowledge

Job description

Alcon is seeking a Quality & Regulatory Affairs professional in Switzerland to lead all quality activities at the country level and ensure compliance with ISO 13485, EU MDR (as applicable) and GDP requirements. The role drives continual improvement of quality oversight for APL and the Representative Offices.

You will promote a strong quality culture, mentor QA staff, perform QMS oversight as the Quality Management Representative, coordinate audits, CAPA, supplier qualifications and regulatory