Qa Engineer Software Development
WHAT ARE YOUR RESPONSIBILITIES?
- You will provide input from a quality and compliance perspective to software development and validation teams
- You will support the creation of the software development, verification and validation documents and to review them for adherence to relevant QMS processes
- You will support the roll-out of the software products from a Quality perspective, as defined per project plans
- You will follow-up Quality events (deviations, design changes) related to software products, more specifically to support event owners and/or stakeholders with regard to investigation, root cause analysis and definition/implementation of action plans related to software products; to verify on completeness of the investigation and to motivate impact assessments and disposition decision, if applicable
WHO ARE WE LOOKING FOR?
- You have a master’s degree in life sciences or a PhD (e.g. Biomedical Engineering, industrial pharmacist, bio-engineer, engineering…)
- You have experience in a pharmaceutical/GMP environment
- You have Knowledge of ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP, is an asset
- You have good communication skills and you are a team player
- You have good writing skills in Dutch or French and English
WHAT DOES QBD OFFER YOU?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.