AxoGen is a growing medical device company and has a Tissue Services Quality Manager opening at their corporate office in North Florida.
The Tissue Services Quality Manager is responsible for the maintenance of the Donor Medical Records with interactions with Recovery Agencies related to Donor Medical Records. This position is also responsible for contract laboratory interactions with respect to tissue cultures and for interactions with storage facilities to ensure that the recovered tissue is properly stored and transferred correctly to processors.
Designs and implements policies and procedures to ensure that quality standards are met. Oversees testing of processes and products. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Leads and directs the work of others.
Responsible for the quality assurance file review of recovery documentation and relevant medical records to ensure compliance with AxoGen Quality Management System and AATB standards as well as FDA, state and international regulations to determine donor eligibility.
Responsible for Medical Records content and filing
Responsible for the maintenance of the donor database.
Responsible to communicate with/guide Tissue Recovery Partners on pending items required to complete donor eligibility documentation
Responsible for tracking, receiving, inspection and processing of in-coming donated tissue, including set up of microbiological cultures.
Assists Operations in interacting with recovery partners
Responsible for understanding serology and preprocessing culture test requirements and for tracking donor serology and preprocessing culture testing to ensure that appropriate testing was performed by a qualified lab.
Assists Operations in interacting with contract laboratories including maintenance of approved procedures
Authority to approve contract laboratories procedures
Development of audit reports and follow-up to internal and external audits
Participate MRB/QAU meetings
Assist in investigations including closures
Quality Management System
Assist in the development of practices and procedures to ensure continued compliance of AxoGen’s Quality Management System to international, federal (21 CFR §820, §1271, §210/211, §600) state and AATB regulations/standards
Assists in Training Programs
Works with AxoGen Staff to ensure Quality Management System compliance
Authority to release Medically approved tissue to Operations for processing
Authority to issue destruction instructions for tissue that is not medically approved for processing
Authority to release medically approved tissue to Clinical & Translational Sciences for research and product development purposes.
Responsible for supervision of staff including performance reviews and development plans.
Responsible for budget development.
Bachelor’s degree in engineering or a related degree
At least 5 years of experience in regulatory/quality
Problem solving using root cause methodologies
Experience working with suppliers to ensure compliance to regulations
Quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
Desirable but not required:
Certified Tissue Bank Specialist
Lead auditor certification
Travel Requirements are up to 15%
Internal Number: 201801
About AxoGen Corporation
AxoGen (NASDAQ: AXGN) is a leading medical technology company focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient’s quality of life.
AxoGen’s portfolio of regenerative medicine products is available in the United States, Canada and several other countries and includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with an additional surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix (“ECM”) coaptation aid for tensionless repair of severed nerves, and AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerve...s and reinforce the nerve reconstruction while preventing soft tissue attachments. AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.