QA Engineer - Documentation & Training (GMP/ISO)

Merz Aesthetics; Plan-les-Ouates; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Merz Aesthetics is seeking a Quality Assurance Engineer specializing in Documentation and Training to strengthen our quality systems in Plan-les-Ouates, GE. You will develop and maintain SOPs, lead training initiatives, and drive CAPA investigations while coordinating with operations and QA teams.

The role requires a Master’s degree and at least five years’ experience in regulated QA, with fluent English and French.

Qualifikationen

• Master's degree in Biotechnology, Engineering, Quality, or a related field.
• Minimum 5 years of experience in Quality Assurance within a regulated environment.
• Strong knowledge of GMP, ISO 13485, and QA principles.

Aufgaben

• Develop, review, and maintain quality documentation (SOPs, work instructions, quality manuals).
• Design and deliver training programs for QA processes and documentation control.
• Lead CAPA processes, investigations, and root-cause analysis.
• Conduct internal audits to assess compliance and identify improvements.
• Collaborate with cross-functional teams to gather documentation needs.
• Use data analysis to monitor quality metrics and drive improvements.
• Manage document control system and ensure proper versioning and archiving.
• Support operations with quality guidance and act as SME for QA topics.
• Maintain high attention to detail to ensure safety and product integrity.

Kenntnisse

GMP & ISO13485

Documentation control

CAPA management

Internal audits

Data analysis

Cross-functional collaboration

Communication skills

MS Office

QMS

Fluent English & French

Ausbildung

Master's degree in Biotech/Engineering/Quality

Tools

Quality Management Systems

AI-enabled tools

Data analysis software

MS Office

Jobbeschreibung

Merz Aesthetics is seeking a Quality Assurance Engineer specializing in Documentation and Training to strengthen our quality systems in Plan-les-Ouates, GE. You will develop and maintain SOPs, lead training initiatives, and drive CAPA investigations while coordinating with operations and QA teams.

The role requires a Master’s degree and at least five years’ experience in regulated QA, with fluent English and French.