Redefine Your Future with TransMedics
Quality Specialist
Redefine Your Future with TransMedics, Andover, Massachusetts, United States, 01810
Quality Assurance Specialist
This position is five days on site at our Andover, MA location. Position Summary This position involves ensuring products meet established quality standards and specifications at various points of the manufacturing process. Duties include examining perfusion units and accessories from pre-sterile inspection through post sterile acceptance and release to finished goods. Key responsibilities include review of documentation, labeling, test reports and certificates. Monitoring product and processes by identifying and addressing defects, maintaining records and collaborating with various teams to improve quality. Responsibilities This position is responsible for, but not limited to, the following: Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures. Review of paper and electronic records of components, sub-assemblies and final assemblies for conformance to specification. Review and release of sterilization loads, which includes, but not limited to, the review of sterilization process data and biological indicator test results. Identify and report non-conformances of product, documentation or sterilization cycle. Complete product release activities of products post sterilization. Provide support to meet department and company objectives. Maintain compliance with all company policies and procedures (safety, regulatory, etc.). Perform other TransMedics tasks and duties as assigned/required. Minimum Qualifications Associates Degree and one year experience in DHR or batch record review or three years' experience in an FDA regulated environment. Experience working with team members to correct documentation non-conformances. Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred. Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously. Preferred Qualifications Must be detail and quality oriented. Excellent interpersonal skills, excellent written and oral communication skills. Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. 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.
This position is five days on site at our Andover, MA location. Position Summary This position involves ensuring products meet established quality standards and specifications at various points of the manufacturing process. Duties include examining perfusion units and accessories from pre-sterile inspection through post sterile acceptance and release to finished goods. Key responsibilities include review of documentation, labeling, test reports and certificates. Monitoring product and processes by identifying and addressing defects, maintaining records and collaborating with various teams to improve quality. Responsibilities This position is responsible for, but not limited to, the following: Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures. Review of paper and electronic records of components, sub-assemblies and final assemblies for conformance to specification. Review and release of sterilization loads, which includes, but not limited to, the review of sterilization process data and biological indicator test results. Identify and report non-conformances of product, documentation or sterilization cycle. Complete product release activities of products post sterilization. Provide support to meet department and company objectives. Maintain compliance with all company policies and procedures (safety, regulatory, etc.). Perform other TransMedics tasks and duties as assigned/required. Minimum Qualifications Associates Degree and one year experience in DHR or batch record review or three years' experience in an FDA regulated environment. Experience working with team members to correct documentation non-conformances. Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred. Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously. Preferred Qualifications Must be detail and quality oriented. Excellent interpersonal skills, excellent written and oral communication skills. Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. 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.