Quality Engineer- Medical Device- East Brunswick, NJ

The Quality Engineer will be responsible for ensuring compliance with medical device standards, driving root cause analysis, corrective actions, and continuous improvement through statistical and risk management practices. The position involves supporting validations, environmental monitoring, and quality system reporting to uphold product reliability and regulatory requirements. Lead or support investigations into product issues, identify root causes, and implement corrective and preventive measures. Apply risk management practices to ensure compliance with industry standards and maintain accurate documentation. Oversee environmental monitoring programs and address any deviations effectively. Provide guidance and support for calibration activities to ensure equipment reliability. Develop and execute validation protocols, technical studies, and test method validations, including data analysis and reporting. Use statistical process control and Six Sigma methodologies to evaluate processes and drive continuous improvement. Interpret and apply standards related to sterilization and product testing to create or refine procedures. 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.Competitive compensation and benefitsGrowth opportunity within an established organization Bachelor’s degree in microbiology, biology, biomedical engineering, or a related scientific discipline 2-6 years of experience in a regulated industry, ideally medical devices or similar fields Solid understanding of quality systems and compliance standards (e.g., ISO 13485, ISO 14971) Skilled in root cause analysis, corrective and preventive actions, and risk management practices Proficient in statistical tools, process control, and Six Sigma methodologies for continuous improvement Hands-on experience with validations, technical studies, and test method development Comfortable using MS Word, Excel, PowerPoint, and Outlook for documentation and reporting Strong oral and written communication skills to collaborate effectively across technical and manufacturing teams The client is a global medical technology company that designs, manufactures, and distributes devices used in surgical and healthcare settings. They are committed to maintaining strict regulatory compliance and high product quality standards, with a focus on innovation, reliability, and patient safety. Their operations emphasize continuous improvement, risk management, and adherence to international medical device standards. Challenging role with exposure to advanced manufacturing processes and regulatory standards Professional growth opportunities through technical development and leadership skill-building Collaborative environment that values teamwork, innovation, and continuous improvement Commitment to quality and compliance, ensuring products meet the highest industry standards Meaningful impact by contributing to safe, reliable medical technologies that improve patient outcomes Michael Page

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