Senior Quality Systems Engineer

Job Description: Senior Quality Systems Engineer POSITION SUMMARY We are seeking a dynamic, analytical thinking individual to join our Quality team, focusing on Quality Systems, CAPA, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Support external audits and inspections by providing subject matter expertise Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Lead/participate in Risk Management and FMEA initiatives Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes and special projects, as required Perform other TransMedics tasks and duties as assigned/required MANAGEMENT RESPONSIBILITIES This position will not have management responsibilities PHYSICAL ATTRIBUTES Must be able to lift 50lbs MINIMUM QUALIFICATIONS Bachelor’s Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 5-7 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR Ability to multi-task, handling multiple projects and changing priorities Experience in the creation and documentation of procedures and processes Must be results-driven and exhibit a sense of urgency Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required PREFERRED QUALIFICATIONS: Experience participating in internal and external audits, preferably serving as qualified internal auditor Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written) Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Ability to act independently to determine methods and procedures Problem-solving skills and the ability to resolve issues as they arise Strong interpersonal skills, with the ability to assimilate with various cross-functional teams TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.