Senior Quality Assurance Engineer – Change Control & Complaints

About the role

We are looking for a Senior Quality Assurance Engineer to lead change control and complaint management for our medical aesthetic products in Lonay, Switzerland. The role ensures compliance with regulatory standards and drives continuous quality improvement.

Key responsibilities

• Lead and coordinate the Change Control process, from assessment and approval to implementation, training, and effectiveness monitoring.
• Review, approve, and investigate product complaints, monitor trends, and support risk management based on post‑market surveillance data.
• Support internal, external and regulatory audits and inspections, and drive quality improvement initiatives.
• Manage deviations, non‑conformances and CAPAs, ensuring compliance with medical device and pharmaceutical regulations.
• Utilize approved digital and AI‑enabled tools for analysis, reporting, documentation and continuous improvement.

Required profile

• Master’s degree in medicine, pharmacy, engineering, quality or a related scientific discipline.
• Minimum 7 years of professional experience, including at least 5 years in Quality within the medical device or pharmaceutical industry.
• Strong analytical, problem‑solving and risk‑based decision‑making abilities.
• Excellent attention to detail, organizational skills and the ability to work independently.
• Fluent in English; French is a plus.

Required skills

• Knowledge of ISO 13485, ISO 14971, FDA Quality System Regulations and GMP.
• Proficiency with Microsoft Office applications.
• Experience with Quality Management Systems and digital/AI‑enabled quality tools.

What we offer

• Work‑life balance with flexible arrangements.
• Opportunities for professional development in a global, family‑owned company.