Quality Engineer

We've partnered with a rapidly growing medical device manufacturing organization looking to hire multiple Quality Engineering positions in support of a large scale‑up initiative at an exciting time in their growth as they expand their manufacturing capabilities. These are pivotal roles focused on driving new revenue, opening new accounts, and building long‑term client partnerships. If you thrive in fast‑paced production environments, enjoy solving manufacturing quality and validation challenges, and want to support a high‑growth medical device organization during a critical scale‑up phase, this opportunity is for you! Quality Engineer Role Summary Support day‑to‑day Manufacturing Quality Engineering activities on the production floor Partner with Manufacturing, Quality, Engineering, Operations, and R&D teams to resolve production quality issues Support manufacturing scale‑up, production ramp, and new product/process introduction activities Lead or support investigations related to NCRs/NCMRs, deviations, CAPA, root cause analysis, and corrective actions Support process validation, equipment validation, inspection readiness, and documentation activities including IQ/OQ/PQ Review and analyze quality data, inspection results, and manufacturing trends to identify issues and drive improvements Support risk management activities including FMEA, process controls, and quality planning Help ensure products, processes, and documentation meet internal quality, regulatory, and customer requirements Quality Engineer profile Quality Engineering experience within medical device, advanced manufacturing, or another regulated manufacturing environment Experience with process validation, equipment validation, IQ/OQ/PQ, inspection methods, and validation documentation Strong hands‑on experience supporting production quality, manufacturing investigations, NCR/NCMR, CAPA, deviations, and root cause analysis Comfortable working cross‑functionally with Manufacturing, Engineering, Quality, Operations, and R&D teams in a fast‑paced production environment Preferred Experience Medical device manufacturing quality experience Knowledge of GD&T, Gage R&R, metrology, inspection strategy, FMEA, SPC, or process capability Experience supporting manufacturing scale‑up, production ramp, NPI, or new equipment/process implementation Experience with automated manufacturing, advanced manufacturing, machining, or complex mechanical products Why this role? High‑visibility role supporting a major manufacturing expansion initiative Opportunity to make a direct impact on production readiness, quality systems, and manufacturing performance Hands‑on role with strong cross‑functional exposure across Manufacturing, Engineering, Quality, and Operations Long‑term growth potential with a rapidly scaling medical device manufacturing organization Ideal for a hands‑on Quality Engineer who enjoys solving production quality challenges, supporting validation and manufacturing readiness, and playing a key role in a fast‑paced scale‑up environment #J-18808-Ljbffr