Senior Manufacturing Process Engineer

Senior Manufacturing Process Quality Engineer QE4 Location: New Hampshire onsite Duration: 12 months Priority HighWe are actively hiring a Senior Manufacturing Process Quality Engineer to support a Class II IVD and electromechanical medical device manufacturing environment. This is a fully hands on role focused on manufacturing floor quality operations, working closely with Manufacturing Engineering, Validation, and Operations teams.Key Responsibilities: Support and execute process validations including IQ OQ PQ Perform and remediate test method validations Develop and maintain PFMEA and control plans Drive CAPA activities including root cause analysis and effectiveness checks Support in process and final inspection strategies aligned to CTQ parameters Provide daily manufacturing floor quality support in a high volume environment Drive continuous improvement initiatives using data driven approaches Ensure compliance with FDA 21 CFR 820 and ISO 13485Must Have Skills: Strong experience in manufacturing process quality not design assurance or NPI Hands on experience in high volume or automated manufacturing environments Strong knowledge of validation activities IQ OQ PQ and TMV Experience with CAPA PFMEA and control plans Working knowledge of SPC Six Sigma and DOE Ability to work directly on the production floor and support operationsPreferred Experience Class II IVD diagnostics manufacturing Liquid reagent filling processes Electromechanical or capital equipment background Familiarity with EU IVDRAdditional Notes W2 only Immediate interviews and quick closure Looking for candidates who can make an immediate impact