Manufacturing Quality Engineer

Manufacturing Quality Engineer IV - $120k - $135k My Client A clinical stage medical device company, pioneering the development of long-term therapy for patience with biventricular heart failure. We are seeking a Manufacturing Quality Engineer IV to play a vital role in ensuring the quality and reliability of life-saving medical devices. This position is central to driving activities associated with the manufacture, test and distribution of the Total Artificial Heart (TAH) system. The Manufacturing Quality Engineer IV (MQE IV) will manage daily QA activities, including validation and verification testing, inspections, and manufacturing process development. They will collaborate with cross-disciplinary engineering teams, support design control efforts (e.g., hazard analysis, FMEAs), and liaise with external suppliers to ensure quality standards are met. The MQE IV will identify and address product and process issues, provide solutions, document feedback, and verify their implementation. This role requires strong technical, organizational, and analytical skills, along with the ability to multitask, problem-solve, and work independently in a fast-paced, deadline-driven environment. RESPONSIBILITIES Ensure compliance with quality standards (21 CFR 820, 803, 806, ISO 13485). Identify and implement quality improvement opportunities and methods to inspect, test, and ensure reliability of processes, products, and equipment. Collect, analyze, and summarize data to prepare reports. Train staff on quality management tools, techniques, and best practices while mentoring junior team members. Develop and maintain documentation for design controls, quality systems, SOPs, and WIs. Define and implement processes to ensure product and process quality, including material control, sampling, and measurement systems. Assist in test method development and validation, regulatory documentation, and risk management activities (ISO 14971, FMEA, FTA). Oversee sterilization validation, clean room maintenance (min. Class 8), and new facility/process implementation. Inspect components, coordinate testing, and interact with external suppliers to develop quality agreements, conduct audits, and address audit queries. Support complaint handling, CAPA investigations, and failure analyses. Lead quality system improvements, address non-conformities, and participate in external audits, reporting progress to the executive team. REQUIREMENTS Bachelor’s degree or higher in Biomedical Engineering or related field, with 8 years in medical device development or quality assurance. Minimum 5 years in Class II/III medical device companies; experience with Ventricular Assist Devices is highly valued. Expertise in electrical/mechanical systems for medical devices in regulated environments. Strong knowledge of design controls, verification/validation, and quality systems (QSR, ISO 13485, ISO 14971, 21 CFR Part 820). Experience with risk management tools (FMEA), statistical analysis, and quality improvement techniques. Familiarity with audit processes, including planning, execution, and follow-up, as well as domestic/international standards. Proven ability to develop and implement quality programs, track/report metrics, and solve problems. Proficiency in Microsoft Office; experience with project planning tools, DAQ systems, and MATLAB is a plus. Certification from the American Society for Quality (CQE, CRE, CSQE, or CBA) is desirable. Experience in Design Assurance through all phases of product development is a plus. Knowledge of gauges, precision inspection equipment, and quality philosophies, principles, and tools.