Quality System Engineer (m/f/d)

Quality System Engineer (m/f/d)

Techfirm Engineering is looking for a Quality System Engineer (m/f/d) to join our team in the french speaking part of, Switzerland.

In this role, you will support the effective deployment, compliance, and continuous improvement of the Quality Management System (QMS) within a regulated medical and technical environment.

You will contribute to quality system improvement initiatives, audit readiness, record management, CAPA, root cause analysis, regulatory documentation, and new product development activities.

What You Will Do:

• Support the effective deployment and application of Quality Systems across the organization.
• Perform periodic checks and reviews to verify appropriate application of quality processes and procedures.
• Act as a Records Coordinator, supporting record management activities and the creation, organization, and maintenance of archives.
• Support audit readiness and participate in internal and external audits.
• Assist with the investigation, response, and remediation of **site-specific Quality System audit observations.
• Identify root causes of quality issues and develop appropriate corrective actions and recommendations.
• Support and follow up on CAPA and corrective action plans, ensuring timely and effective implementation.
• Lead or participate in Quality System improvement and continuous improvement initiatives.
• Use quality tools, statistical methods, and data-driven reports to support process capability and quality improvements.
• Identify opportunities for process changes and improvements where appropriate.
• Establish and maintain effective quality-related communication to increase awareness and promote continuous improvement across the business.
• Support the implementation of new product development procedures and documentation.
• Review regulatory and quality documentation to ensure compliance with applicable requirements.
• Communicate business-related quality issues and opportunities to relevant stakeholders and management.
• Support compliance with applicable Health, Safety & Environmental requirements, as well as company policies and procedures.

What We Are Looking For:

• Bachelor's or Master’s degree in Quality, Engineering, Life Sciences, Medical/Technical field, or a related discipline.
• Previous experience in a medical, pharmaceutical, biotech, MedTech, or technical industry.
• Experience in Quality Systems and Quality Management within a regulated environment.
• Previous experience with record management and quality documentation.
• Experience supporting internal and external audits.
• Good knowledge of CAPA, root cause analysis, corrective actions, and quality investigations.
• Experience with continuous improvement and Quality System improvement initiatives.
• Ability to work with quality data, statistical methods, and quality tools.
• Good understanding of regulatory and quality requirements.
• Strong documentation, organizational, and analytical skills.
• Good knowledge of Microsoft Office and confidence working with computer-generated reports.
• Strong communication and stakeholder management skills.
• Rigorous, structured, and detail-oriented approach.
• Ability to work independently as well as within cross-functional and multicultural teams.

Languages & Requirements:

• French: fluent.
• English: fluent.
• Valid Swiss/EU/EFTA work authorization.

Why Techfirm?

At Techfirm Engineering, you will:

Join a Swiss-headquartered company with a multicultural and collaborative environment.

Work on impactful Life Sciences, MedTech, pharmaceutical, and industrial projects across Switzerland.

Contribute to challenging Quality System and compliance projects in regulated environments.

Collaborate with international experts and multidisciplinary teams.

Develop your expertise through challenging and meaningful assignments.

Be part of a company culture focused on respect, professional growth, and employee well-being.

Please note: only candidates with valid Swiss/EU/EFTA work authorization can be considered.