Senior Product Quality Engineer

Role Overview

• Ensure compliance with and implementation of Clario control processes (e.g., PLC, DLC, SDLC) across assigned global projects.
• Review development and technical documentation during global design projects, ensuring alignment with applicable standards and regulations.
• Provide quality and regulatory guidance to cross‑functional teams throughout the full product lifecycle.
• Ensure medical and non‑medical devices and solutions comply with applicable regulations and standards (e.g., ISO, FDA, MDR).
• Contribute to product reviews and design control activities.
• Support validation activities to confirm products meet intended use and indications for use requirements.
• Partner with internal departments to resolve quality issues and support continuous improvement initiatives.
• Support the Quality Management designee and participate in quality surveillance activities.
• Support the revision and maintenance of procedures, policies, and work instructions to ensure compliance with local and international regulations.
• Support internal and external audit activities, including project‑specific audits, to ensure compliance with Clario’s QMS.
• Serve as a member of the Designated Complaint Unit (DCU) and fulfill responsibilities as outlined in the associated appointment letter.
• Report project status, risks, deviations, and quality concerns to management, including recommended corrective actions.

Requirements

• Bachelor’s degree in Engineering (technical or electrical), Life Sciences, or an equivalent discipline.
• At least 5 years of experience working with Design Controls (e.g., Computer System Validation) or Quality Management Systems in a regulated environment.
• At least 5 years of experience in GMP and/or GCP regulated environments.
• Experience supporting Agile development in a regulated environment.
• Minimum 2 years of hands‑on experience working with ISO and/or GCP standards.
• Auditor experience in a GCP/GMP environment is preferred.
• Strong troubleshooting, communication, and stakeholder‑management skills.
• Professional working proficiency in English.
• Willingness to travel internationally (up to 25%).

Tech Stack

• Google Cloud Platform
• SDLC

Benefits

• Competitive compensation
• Flexible working hours and working time accounts to support the work-life balance.
• Support your professional development through internal and external training and certification programs.
• Attractive benefits (security, flexibility, support and well-being).
• Engaging employee programs.