Senior Quality Engineer

A growing precision manufacturing organization supporting the medical device industry is expanding its quality team and seeking a Senior Quality Engineer to play a key role in driving process improvement, product quality, and compliance across production operations.This position is highly integrated with manufacturing, engineering, and operations, supporting both ongoing production and new product introduction within a fast-paced, high-volume environment. The organization offers a diverse range of manufacturing capabilities including CNC machining, metal stamping, wire EDM, forming, and metal injection molding (MIM), supporting full lifecycle development from prototyping through scaled production.What You’ll Be DoingProvide hands-on quality engineering support directly on the manufacturing floorAnalyze production and process data to identify trends, reduce downtime, and improve yieldLead root cause analysis and drive corrective and preventive actions (CAPA) for non-conforming materialsDevelop and maintain quality documentation including APQP, SOPs, control plans, and work instructionsExecute PPAP submissions and First Article Inspection Reports (FAIR)Perform dimensional inspections using precision metrology tools including calipers, micrometers, and gauge pinsConduct Gage R&R and measurement system analysis (MSA)Support internal audits and maintain compliance with ISO 9001 and ISO 13485 standardsPartner with engineering on new product launches, process validation (IQ/OQ/PQ), and continuous improvement initiativesWhat We’re Looking ForBachelor’s degree in Engineering or related technical disciplineA minimum of 10 years of quality engineering experience within a manufacturing environmentExperience working within ISO 9001 and/or ISO 13485 quality systemsStrong knowledge of Lean Manufacturing, Six Sigma, SPC, FMEA, and continuous improvement toolsHands-on experience with metrology and inspection equipmentFamiliarity with ERP systems and Microsoft Office toolsAbility to work cross-functionally and drive problem-solving initiatives on the production floorThis is an opportunity to join a collaborative team focused on quality, innovation, and continuous improvement within a technically diverse manufacturing environment.KeywordsQuality Engineering | Manufacturing Quality | ISO 9001 | ISO 13485 | APQP | PPAP | FAIR | CAPA | Lean Manufacturing | Six Sigma | SPC | FMEA | MSA | Gage R&R | Process Validation | IQ OQ PQ | Metrology | CNC Machining | Metal Injection Molding | Precision Manufacturing | Medical Device Manufacturing#QualityEngineer#ManufacturingQuality#ISO13485#MedicalDeviceJobs#CNCMachining#ProcessValidation