ARCQ is a staffing- and recruitment agency with a focus on the life sciences.
Quality Engineer Product
Purpose of the job
- Ensure that in-vitro diagnostic test kits are developed and maintained during the whole product life cycle to meet customer expectations and in compliance with current quality and regulatory requirements;
- Ensure customer satisfaction by providing appropriate solutions to customer complaints in a timely manner as part of an outstanding post-sales service.
- You review and approve technical documentation generated during the development process and improvement projects to ensure compliance towards applicable procedures;
- You participate to design review meetings and act as quality expert in project teams;
- You own and maintain the product risk management file from launch of the products;
- You write and/or approve changes and CAPA’s;
- You handle and follow-up product complaints from end users, affiliates, distributors and partners and provide timely and appropriate solutions;
- You discuss complaints which could have consequences on public health and liaise with the Risk Assessment Committee in case of potential Reportable Events;
- You provide support to the QC department (troubleshooting, training, expertise, …);
- You optimise, validate and implement QC methods and procedures (QC, FQC, Stability, Sampling) in order to guarantee product quality until end of shelf life.
- Master degree in bio-environment (pharmaceutical sciences, biology, biotechnology) or equivalent by experience;
- Minimum 3 years quality experience in pharmaceutical or diagnostic environment;
- Languages: good knowledge (written & spoken) of Dutch and English.
- Insight in customer and market requirements;
- Positive, pro-active and flexible attitude;
- Experience in CAPA is a plus;
- Team player: open minded, cooperative, takes initiative;
- Good problem solving – problem analysis;
- Project management experience.