Join a supporting breakthrough medical devices Lead high-impact quality initiatives in a rapidly expanding operation About Our Client Our client is a rapidly growing advanced manufacturing organization that partners with leading medical technology companies to develop innovative products that improve patient outcomes worldwide. With significant recent investments, expanded capabilities, and a strong culture of engineering excellence, they offer professionals the opportunity to work on cutting-edge technologies in a highly collaborative environment. Job Description Lead quality engineering activities for new product introductions, process improvements, and manufacturing optimization projects. Drive root cause investigations, CAPAs, nonconformance resolution, and risk mitigation activities using advanced quality tools. Develop and execute validation protocols, test methods, equipment qualifications, and process validations. Establish and maintain quality control plans, SPC programs, inspection methodologies, and process monitoring systems. Partner with customers, suppliers, and internal stakeholders to resolve quality issues and ensure regulatory compliance. Support ISO 13485 and FDA-regulated operations through audits, documentation, training, and continuous improvement initiatives. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. The Successful Applicant A successful Quality Engineer should have: Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field. Experience in Quality Engineering within a medical device manufacturing environment. Working knowledge of

ISO 13485, FDA 21 CFR

820, and regulated quality systems. Experience with validations, risk management, CAPA investigations, and quality documentation. Strong statistical analysis skills, including experience with Minitab or similar software. Excellent technical writing, communication, and project leadership abilities. What's on Offer Salary range of $70,000 to $100,000. Work directly on implantable and life-saving medical technologies. Join a recently expanded manufacturing center with significant investment and growth. Gain exposure to structural heart, neurovascular, and minimally invasive device programs. Lead impactful quality initiatives with high visibility across operations and engineering. Enjoy long-term career growth opportunities within a global medical device manufacturing organization. Interested? Apply today.