What are the responsibilities and job description for the Quality Engineer position at ALOIS Solutions?
Job Details:
Title: Quality Engineer
Location: Irvine, CA
Must Have:
- 3 years of experience in Medical Device (will consider Pharma / Bio-Med - but preference is Med-Device).
- Hosting Audits.
- Someone leading Material Review meetings - OOTs, OOSs, etc.
- Some sort of Supplier Quality Background.
- Someone who understands non-conformance process.
Job Description:
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.
