Manufacturing Quality Engineer

Alexander Technology Group is looking for Manufacturing QA Engineer for a client in the Portsmouth, area. This is full-time and on-site.No 3rd party c2c applicants will be considered, do not reach outKey ResponsibilitiesProvide on-the-floor quality engineering support to manufacturing operations for combination products.Perform and document line clearances prior to batch start, product changeovers, and as required throughout production.Ensure labeling control requirements are met. Conduct incoming inspection of components and materials (visual, dimensional, and functional tests as applicable).Perform batch record reviews (BRR) for completeness, accuracy, and GMP compliance.Ensure that all work adheres to applicable cGMP, ISO, and FDA regulatory requirements for combination products.QualificationsBachelor’s degree in Engineering, Life Sciences, or a related technical field — or equivalent practical experience.3-5 years prior experience in a regulated manufacturing environment (pharma, medical device, or combination products preferred).Basic understanding of quality systems, cGMP, and data integrity principles.Experience with combination product manufacturing, device assembly lines and/or cleanroom experience.Knowledge of FDA 21 CFR Part 4, 210, 211 and 820, ISO 13485, or similar regulatory standards.If interested, please send resume to josh at