Quality Engineer

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Quality Engineer you act as the independent quality authority for assigned products, ensuring compliance with cGMP and regulatory expectations. 
• You review and approve process, method, filter, and component validations, as well as raw material evaluations and Design History Files (DHF).
• You verify data and perform QA reviews for marketing authorization filings, variations, and regulatory responses. 
• You perform compliance checks between site practices and registration dossiers for all relevant markets. 
• You ensure correct and timely implementation of approved regulatory changes at the site. 
• You follow up on market approvals and commitments to maintain CMC compliance. 

Requirements

• Master's degree in a scientific discipline (e.g. Pharmacy, Biomedical Sciences, Bio-engineering) or equivalent experience. 
• Two years or relevant experience in the pharmaceutical or medical device industry, or equivalent experience through a PhD. 
• Knowledge or cGMP, regulatory guidelines, and applicable medical device and combination product regulations. 
• You demonstrate a strong quality mindset and pragmatic approach to problem-solving. 
• You possess excellent analytical, oral, and written communication skills. 
• Fluent in Dutch and English

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.