Salary will be based off of experience within field
4 Year Degree
Employer will assist with relocation costs.
Internal Number: 1117
The Quality Systems Coordinator (QSC) is responsible for supporting the work of Surgenex’s quality systems with direct oversight of the occurrence reporting. This includes nonconformances (NCR), deviations, and complaints with the development and implementation of Corrective and Preventive action (CAPA) plans as well as conducting verification of effectiveness (VOE) checks. Facilitate root cause analysis for required reported events in accordance to the established procedures. The QSC will assist and facilitate in collaboration with key stakeholders, defining, framing and structure development of the organizational change management strategies.
Assists with ensuring compliance to state, federal, local, international, and accrediting agency regulations, and standards as well as Surgenex procedures.
Responsible for supporting the Director of Quality Systems with the execution of the occurrence reporting system, ensuring all events are reported, investigated, and ensuring effective actions are implemented.
Responsible for conducting verification of effectiveness within the established timeframes to ensure timely closure.
Facilitate root cause analysis applying the use of quality tools including and not limited to brainstorming, Ishikawa diagram-fishbone, DMAIC, 5 whys.
Provide statistical reports based on the tracking and trending of the occurrences and root causes to assist departmental management in identifying opportunities for improvement (OFIs).
Support the development and effective implementation of an organizational wide change management system including development of strategies, plans and activities in support of key business objectives including but not limited to new or updated products, processing, and administrative processes.
Foster smooth current-to-future state change transitions for all stakeholders with focused strategies to achieve optimal outcomes.
Other duties as assigned.
Accuracy - Ability to perform work accurately and thoroughly.
Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
Conflict Resolution - Ability to deal with others in an antagonistic situation.
Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
Detail Oriented - Ability to pay attention to the minute details of a project or task.
Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.
Organized - Possessing the trait of being organized or following a systematic method of performing a task.
Responsible - Ability to be held accountable or answerable for one’s conduct.
Self Confident - The trait of being comfortable in making decisions for oneself.
Time Management - Ability to utilize the available time to organize and complete work within given deadlines.
Communication - Ability to communicate effectively with others.
Adaptability - Ability to adapt to change in the workplace.
Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards, or legislation.
Education: Bachelor's Degree in physical sciences or quality studies is required. Equivalent work experience may be substituted for education.
Experience: Four to six years document control experience in regulated or certified industry.
Computer Skills: Proficient with Microsoft office suite
Surgenex is a biotechnology company that specializes in the development and production of regenerative medicine products. They focus on using advanced technologies to harness the therapeutic potential of human tissue-derived materials.
Surgenex is known for its flagship product called Umbilical Cord Matrix (UCM) and Umbilical Cord Blood (UCB) products. These products are derived from donated umbilical cord tissue and blood collected during the birth of healthy, full-term babies. The company utilizes a proprietary processing method to obtain mesenchymal stem cells, growth factors, cytokines, and other biologically active components from these tissue sources.
The regenerative medicine products developed by Surgenex are used for various medical purposes, including wound healing, pain management, orthopedic applications, and tissue regeneration. They are often used in conjunction with other medical interventions to support the body's natural healing processes.