Job Title: System Quality Engineer

Department: Quality Assurance

Location: Renens

Starting date: August 2025

Job Summary:

The System Quality Engineer is responsible for ensuring that integrated systems, including sub-systems, meet all quality and regulatory standards. This role involves developing, implementing, and managing quality assurance processes, conducting rigorous testing and validation, and working closely with cross-functional teams to drive continuous improvement in system quality.

Key Responsibilities:

1. Quality Assurance and Control:
   • Develop and implement quality assurance processes for system and sub-system manufacturing.
   • Create and maintain detailed documentation of quality standards, procedures, and inspection protocols.
   • Conduct regular inspections and audits to ensure compliance with internal and external standards.
2. System Testing and Validation:
   • Design and oversee testing protocols for system integration, functionality, and performance.
   • Perform validation and verification of systems and sub-systems to ensure they meet design specifications and regulatory requirements.
   • Analyze test results and implement corrective actions for any deficiencies identified.
3. Regulatory Compliance:
   • Ensure that systems and sub-systems comply with industry regulations, such as FDA, ISO, and CE standards.
   • Prepare and maintain documentation required for regulatory submissions and audits.
   • Stay current with changes in relevant regulations and standards and update processes accordingly.
4. Supplier Quality Management:
   • Evaluate and audit suppliers to ensure the quality of components and sub-systems.
   • Develop and maintain supplier quality agreements and monitor supplier performance.
   • Collaborate with suppliers to address quality issues and implement improvements.
5. Non-Conformance and CAPA:
   • Investigate non-conformances related to system quality, perform root cause analysis, and implement corrective and preventive actions (CAPA).
   • Maintain and track non-conformance reports and CAPA documentation.
6. Continuous Improvement:
   • Identify opportunities for process improvements to enhance system quality and efficiency.
   • Lead or participate in cross-functional teams to develop and implement quality improvement projects.
7. Reporting and Documentation:
   • Generate and present quality metrics and reports to senior management.
   • Maintain comprehensive records of quality assurance activities, test results, and compliance documentation.
   • Participate in management reviews and quality assurance meetings.

Qualifications:

• Education: Bachelor’s degree in Engineering, Quality Assurance, or a related field.
• Experience: Minimum of 5 years of experience in quality assurance, preferably in the medical device industry.
• Technical Skills: Proficiency in quality management systems (QMS), statistical analysis, and testing methodologies.