Software Quality Engineer

Proclinical; Schweiz; On-site; CHF 90,000 - 120,000; Full time

Job summary

Proclinical is seeking a Software Quality Engineer in Switzerland to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for SaMD products, including AI-enabled software.

The role collaborates with cross-functional teams to support software lifecycle processes, risk management, and audit readiness, while maintaining traceability across requirements, design, risk, and release.

Qualifications

• Background in systems engineering, software, or a related field.
• Familiarity with ISO 13485, FDA 21 CFR Part 820-QMSR, IEC 62304, and ISO 14971.
• Experience authoring technical documentation for SaMD in regulated environments.
• Ability to translate complex engineering and AI-ML concepts into clear, structured documentation.
• Strong technical writing skills with attention to detail and version control.
• Proven ability to manage documentation across multiple stakeholders and meet tight deadlines.
• Excellent organizational, coordination, and communication skills.
• Flexibility in working style and problem-solving approach.

Responsibilities

• Support and improve software lifecycle processes in compliance with IEC 62304, ISO 13485, and other regulatory requirements.
• Participate in design reviews, verification/validation activities, risk assessments, and release readiness reviews.
• Assist in software risk management, including hazard analysis and traceability of risk controls.
• Maintain software configuration and change management records for compliance and audit readiness.
• Contribute to cybersecurity and Software of Unknown Provenance (SOUP) documentation activities.
• Author, update, and maintain technical documentation, including design inputs/outputs and traceability matrices.
• Ensure documentation aligns with regulatory expectations and approved design changes.
• Establish and maintain end-to-end traceability across requirements, design, risk, implementation, testing, and release.
• Develop and track documentation plans and timelines aligned with product milestones.
• Support design and documentation reviews, ensuring outcomes are captured and reflected in technical documentation.
• Facilitate audit and inspection readiness by organizing documentation and ensuring traceability.
• Support investigations related to software defects, customer complaints, CAPAs, and post-market feedback.
• Track and manage quality actions, ensuring timely updates to procedures and documentation.

Skills

Systems engineering

Software engineering

Regulatory knowledge

Technical writing

Education

Background in related field

Job description

Keep the heartbeat of innovation running in this Software Quality Engineer position and ensure cutting-edge pharma never miss a beat!

Proclinical is seeking a Software Quality Engineer to contribute to the development and maintenance of technical documentation and ensure compliance with global regulatory and quality standards for Software as a Medical Device (SaMD) products, including AI-enabled software. This role involves collaborating with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.

Responsibilities:

• Support and improve software lifecycle processes in compliance with IEC 62304, ISO 13485, and other regulatory requirements.
• Participate in design reviews, verification/validation activities, risk assessments, and release readiness reviews.
• Assist in software risk management, including hazard analysis and traceability of risk controls.
• Maintain software configuration and change management records for compliance and audit readiness.
• Contribute to cybersecurity and Software of Unknown Provenance (SOUP) documentation activities.
• Author, update, and maintain technical documentation, including design inputs/outputs and traceability matrices.
• Ensure documentation aligns with regulatory expectations and approved design changes.
• Establish and maintain end-to-end traceability across requirements, design, risk, implementation, testing, and release.
• Develop and track documentation plans and timelines aligned with product milestones.
• Support design and documentation reviews, ensuring outcomes are captured and reflected in technical documentation.
• Facilitate audit and inspection readiness by organizing documentation and ensuring traceability.
• Support investigations related to software defects, customer complaints, CAPAs, and post-market feedback.
• Track and manage quality actions, ensuring timely updates to procedures and documentation.

Key Skills and Requirements:

• Background in systems engineering, software, or a related field.
• Familiarity with ISO 13485, FDA 21 CFR Part 820-QMSR, IEC 62304, and ISO 14971.
• Experience authoring technical documentation for SaMD in regulated environments.
• Ability to translate complex engineering and AI-ML concepts into clear, structured documentation.
• Strong technical writing skills with attention to detail and version control.
• Proven ability to manage documentation across multiple stakeholders and meet tight deadlines.
• Excellent organizational, coordination, and communication skills.
• Flexibility in working style and problem-solving approach.