Quality Engineer

Quality Engineer (Medical Devices)About the roleIntePros is hiring a Quality Engineer for a leading medical device manufacturer in Mahwah, NJ. You’ll provide hands-on quality engineering support across operations, and help make sure products are free of defects, work as designed, and meet regulatory standards. You’ll develop and implement methods for process control, process improvement, testing and inspection. You’ll also be the voice of Quality across functions, leading projects that improve quality performance and keep the business compliant. This is an individual contributor role for someone who uses sound judgment and works independently with minimal supervision.What you’ll doDevelop, execute and approve First Article Inspection (FAI) strategiesSupport the Production Part Approval Process (PPAP)Manage change control processes and change impact assessmentsPerform equipment and process validationsUpdate and review SOPs and risk management documentationLead quality initiatives and partner with teams across multiple sitesWhat you bringBachelor’s degree in Biomedical Engineering, Mechanical Engineering or a related field2+ years of industry experienceKnowledge of change management and Quality Management Systems (QMS)Strong grasp of engineering and quality conceptsProblem-solving and analytical skills, with close attention to detailExcellent written and verbal communication skills, with the ability to build trust with stakeholdersProficiency in Microsoft Word, Excel and PowerPointA self-starter who handles multiple priorities in a fast-paced environmentNice to haveMedical device industry experienceFamiliarity with ISO 13485, EU regulations, and Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)Knowledge of risk-based and statistical methods