About Us
TransMedics is redefining what’s possible in organ transplantation. The Organ Care System (OCS™), our paradigm-shifting technology platform, is revolutionizing organ transplant. TransMedics OCS is a portable, ex-vivo, normothermic perfusion technology that mirrors human physiology, minimizes ischemia, and provides the ability to optimize donor organs during transport. This pioneering technology allows physicians and institutions to maximize the potential of donor lungs, hearts and livers, while monitoring each organ throughout the entire process, so that patients can experience better outcomes.
Responsibilities:
- Maintains and improves Omnify Quality Management System software
- Recommends and implements potential improvements or enhancements to quality systems and processes
- Leads the Quality Audit system by managing the audit schedule and participating in and leading internal audits
- Leads Quality aspects of the Supplier Management process, e.g., participate/lead supplier audits, presentation of trend data, etc.
- Supports 3rd party audits (ISO, FDA, etc.)
- Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews
- Manages the Corrective and Preventive Action (CAPA) system
- Maintains SOP Training for the Company; ensures employees are assigned appropriate training plans
- Ensures compliance of QMS through SOP updates and training
- Identifies product and process improvements; leads and supports their implementation
- Some travel may be required (approximately 5-10%)
- Performs other TransMedics tasks and duties as required.
Requirements:
- BS in Engineering or technical discipline with at least 8 years experience in Quality Systems Engineering in the medical device manufacturing industry, or equivalent combination of education and experience
- Outstanding project management experience
- Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
- Experience in medical device manufacturing and EtO sterilization of disposable medical devices
- Experience with Quality Auditing to 21 CFR Part 820 and ISO 3485.
- Excellent track record trouble-shooting and applying effective, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues
- Ability to communicate ideas and information clearly, effectively and concisely
- Highly detailed oriented with strong organization and prioritization skills
- Must possess the ability to handle multiple projects and changing priorities
- Must be results-driven and exhibit a sense of urgency
- Six sigma training/certification is a plus
- Experience creating and working with databases, queries and reports is a plus