Join a dynamic team focused on pioneering innovations in the pharmaceutical and medical technology sectors. This project is currently in the developmental phase, where flexibility and adaptability are key to success. Our client is searching for a professional who can navigate through complexities and contribute significantly to their Quality Assurance processes.

As an ideal candidate, you are a seasoned Quality Engineer with a robust background in new product introduction. If you thrive in a fast-paced environment and are excited about shaping quality guidelines based on client needs, this role is designed for you.

• You translate client needs and wants into operational QA guidelines.
• You detect gaps in the Quality Management System (QMS) and implement solutions.
• You conduct risk analyses and ensure comprehensive documentation.
• You negotiate and establish product specifications with clients, aligning with company capabilities.
• You review and approve critical documents relevant to the New Product Introduction Program.
• You initiate and coordinate required risk assessments throughout the project lifecycle.
• You demonstrate confidence in leading operational changes and managing client interactions.

Requirements

• You have over 5 years of experience in a quality function related to new product development or new product introduction.
• You possess knowledge of GMP, and familiarity with ISO 13485 or ISO 15378 will be considered a big plus.
• You are a proactive individual with a hands-on and entrepreneurial approach.
• You have excellent communication skills.
• You are fluent in English (written and spoken); proficiency in Flemish/Dutch and/or French is ideally desired.
• You come from a Pharma, Med Tech, or pharma packaging background.
• You are flexible and able to adapt to evolving requirements throughout the project.