R&D​/Technical Develeopment Quality Lead

Are you passionate about quality and precision? Join our client in this R&D, Quality Lead position and help ensure top-tier standards every day.

Proclinical is seeking a Quality Assurance Lead to support and guide global projects within the medical device sector. In this role, you will provide quality oversight, lead cross-functional teams, and ensure compliance with regulatory standards. This position focuses on driving quality initiatives, supporting technical research and development, and contributing to the successful delivery of high-quality medical devices.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Lead and support global project teams, representing Quality Assurance (QA) in key meetings and decision-making forums.
• Provide quality oversight and guidance for assigned development projects, ensuring compliance with internal and external medical device requirements.
• Develop and align project strategies with organizational goals, including risk assessments and contingency planning.
• Act as the QA representative for technical documentation, ensuring quality standards are met.
• Collaborate with cross-functional teams to manage project-related activities and ensure seamless communication across departments.
• Support impact assessments and actions related to design and manufacturing changes for medical devices.
• Contribute to the creation and maintenance of Quality Management System (QMS) documentation, such as SOPs and work processes.
• Assist in preparing for and hosting Notified Body inspections.
• Approve QA agreements, project-specific amendments, and technical records in systems like Trackwise.
• Monitor and assess new regulations and standards, defining and tracking necessary actions.
• Manage project trackers and prepare materials for governance and management forums.

Key Skills and Requirements:

• Strong understanding of quality standards and policies in medical device manufacturing and control.
• Experience with Notified Body inspections and regulatory compliance.
• Proven expertise in device development and/or Quality Assurance/Quality Control roles.
• Ability to lead interdisciplinary teams and contribute to matrix environments with strategic thinking and quality awareness.
• Proficiency in computer systems, including MS Office and document management tools, with a willingness to learn new systems.
• Fluent in English (oral and written); additional proficiency in a local language is a plus.
• Educational background in a relevant field, such as a Bachelor's or Master's degree in a related discipline.