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Senior Quality Systems Engineer
2 months ago
TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.
We are seeking a dynamic, analytical thinking individual to join our Quality team, focusing on complaint handling, post-market surveillance, 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. QMS experience is essential.
ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:
Key member of the Complaint Handling Unit supporting Class III medical devices, responsible for daily operation of the complaint process and ensuring the prompt resolution of customer complaints.
Document complaints in the complaint management system.
Lead investigation activities to determine root causes.
Communicate with internal groups as needed to obtain additional information to process complaints.
Review complaints to determine whether regulatory authority reporting and/or assessment is warranted.
Maintain excellent working knowledge of company’s products.
Facilitate external communications regarding complaints.
Contribute to post-market surveillance efforts by collecting and managing relevant information, maintaining databases, and assisting in documentation for regulatory reporting.
Drive process improvement initiatives for enhanced field action readiness, involving internal documentation reviews and effective communication with regulatory authorities.
Apply risk assessment principles according to ISO 14971 to make informed decisions related to our processes and products.
Collaborate closely with Regulatory Affairs, Operation, Service, and Quality Assurance teams.
BACKGROUND AND QUALIFICATIONS:
Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering, scientific or related discipline.
Minimum of 3 years’ experience in a Quality Assurance, Quality Engineering, Manufacturing Engineering or other related field in medical device/IVD industry.
Demonstrate proficiency in handling customer complaints, medical device reporting, and post-market surveillance activities.
Comfortable working in biosafety environment (BSL-2).
Experience with manufacturing environment preferred.
Experience with medical capital equipment and electromechanical devices preferred.
Ability to communicate ideas and information clearly, effectively, and concisely.
EDUCATION:
BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline
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.
