What are the responsibilities and job description for the Quality Engineer Medical Device position at ALOIS Solutions?
- The Quality Engineer is responsible for evaluating and controlling product and service quality, working cross-functionally to support the development, maintenance, and continuous improvement of products and processes.
- This role reviews and investigates Non-Conformances (NCs), Deviations (DEVs), Out-of-Tolerance (OOT), and Out-of-Specification (OOS) events, and responds to Corrective and Preventive Actions (CAPAs).
- The engineer sets up and executes internal audits, leads Quality Assurance (QA) and Material Review Board (MRB) meetings, and supports equipment, process, material, and method validation activities.
- They write and execute test protocols, collect and analyze data, and prepare validation reports to ensure products perform as intended.
- The role requires a basic understanding of quality engineering principles, FDA/ISO/cGMP regulatory requirements, and statistical sampling techniques.
- The engineer applies knowledge and skills to complete routine work independently with guidance and develops competence in their area through hands-on experience and collaboration.
Basic Requirements:
- 3 years of experience in Quality Assurance / Quality Engineering in Medical Device (Pharma / Bio-Med also acceptable).
- Bachelor's Degree in Engineering or Science.
