Contract position: Quality Engineer needed for a amazing opportunity in the Boylston, MA area with a high growth company. The Quality Engineer would be working in the New Product Introduction group to provide documentation and coordination support to ensure objectives are met throughout the validation process. Apply now for immediate consideration!Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Drafting Validation documents including FAT, SAT, IQ, OQ, PQ, PPQ and URS
- Draft Validation reports and review attachments including Device History Records
- Development and implementation of statistical incoming and in-process sampling/control plans and submitting Metrology requests.
- Provide updates on project status and support team meetings with customers. Facilitate communication between engineering function, manufacturing, and quality
- Bachelor's degree preferred with 1 - 5 years of related quality experience.
- Understanding and application of Quality systems.
- Medical device, ISO 13485 and IQ/OQ/PQ experience is a huge plus.
- Experience in validation and verification is a huge plus.
- Technical skills in injection molding, tooling, materials, product design, and affiliated processes; to include secondary operations and automation preferred
- Ability to manage multiple small- to medium-scale projects/programs preferred
- Industry leading contractor benefits available! Apply now!