Projects and Processes Engineer

About the role

In this position you will act as the bridge between product development teams and technical documentation, ensuring that manufacturing software and equipment meet the highest quality standards for medical devices.

Key responsibilities

• Define and execute validation strategies and activities for launching and sustaining manufacturing software and equipment.
• Develop detailed validation protocols and test cases.
• Coordinate the Label and Packaging Change Control Board, guaranteeing compliance with international regulations and customer requirements.
• Maintain adherence to Good Documentation Practices and relevant standards throughout the validation lifecycle.

Required profile

• Bachelor’s degree in Mechanical, Mechatronics, Electronics, Computer Science, or a closely related engineering discipline.
• 3–5 years of experience in quality assurance or software/equipment validation, preferably within the medical device industry or a similarly regulated environment.

Required skills

• Strong knowledge of Good Documentation Practices (GDP).
• Familiarity with FDA QSR, ISO 13485, ISO 14971, and IEC 6230 standards.
• Exceptional written and verbal English communication.
• Sharp attention to detail and ability to manage multiple projects simultaneously.