Quality Assurance Engineer Documentation & Training

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

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

Position Snapshot

Job Title: Quality Assurance Engineer Documentation & Training

Location: Plan-les-Ouates (GE)

Activity rate: 100%

Type of contract: CDI

Key Responsibilities

• Develop, review, and maintain comprehensive quality documentation, including Standard Operating Procedures (SOPs), work instructions, and quality manuals, ensuring alignment with Good Manufacturing Practices (GMP) and regulatory requirements.
• Design and deliver engaging training programs for quality assurance processes, documentation control, and relevant operational procedures to all levels of staff.
• Lead the implementation and ongoing management of Corrective and Preventive Action (CAPA) processes, including thorough investigation of deviations and root cause analysis.
• Conduct internal audits to assess compliance with established quality standards and identify areas for process improvement.
• Collaborate with cross-functional teams to gather information for documentation and training materials, ensuring clarity and accuracy.
• Utilize data analysis to monitor quality metrics, identify trends, and recommend data-driven improvements to quality processes and documentation.
• Manage the document control system, ensuring proper version control, distribution, and archival of all quality-related documents.
• Facilitate quality improvement initiatives and contribute to the continuous improvement process across the organization.
• Provide support and guidance to operations teams on quality-related matters, acting as a subject matter expert.
• Maintain a high level of attention to detail in all documentation and training activities, ensuring safety assurance and product integrity.

Knowledge And Skills

• Extensive knowledge of GMP, ISO 13485 requirements, and Quality Assurance principles
• Strong verbal and written communication and presentation skills
• Ability to work independently and manage priorities within tight deadlines
• Strong collaboration and stakeholder management skills across functions, organizational levels, sites, and multicultural environments
• Strong attention to detail, rigor, accuracy, and organizational skills with a commitment to quality and regulatory compliance
• Team-oriented mindset
• Proficiency in Microsoft Office applications, Quality Management Systems, and digital and AI-enabled tools supporting data analysis, process improvement, and documentation activities
• Fluent in English and French

Education & Qualifications

Master's degree (or equivalent Bac +5 qualification) in Biotechnology, Engineering, Quality, or a comparable scientific discipline.

Professional Experience

Minimum 5 years of experience in Quality Assurance within a regulated environment

What We Offer

Work-life balance: Our time is precious; to promote a good work-life integration, we allow flexible working hours and home office work, depending on the position requirements. Our employees also benefit from generous annual leave arrangements.

Ongoing training: Your personal and professional development is key to our success. You will have access to multiple training programs (e.g., LinkedIn Learning, FranklinCovey, Harvard online) and development opportunities.

Benefits: We offer various benefits, such as premium accident insurance, attractive Pension Fund, discounts programs, Employee Assistance Program, and regular fun team activities.

Sustainable development: The Merz Group is investing at every site to achieve carbon neutrality by 2035.