Operations CV Quality Manager

Regeneration Technologies, Inc., prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and proprietary, validated sterilization processes. These allograft and xenograft implants for orthopedic, oral maxillofacial, urinary and cardiovascular surgeries. Biologic implants can be easily used to repair and promote the healing of a wide variety of bone and other tissue defects.

Job Description

This position provides Quality leadership across all aspects of RTI-CV.Responsible for establishing and promoting professional working relationships with BU’s, Quality Assurance, Regulatory, R&D and outside contractors.Responsible for implementing, maintaining and monitoring quality assurance policies and practices.Provides leadership in QRB, NCR’s, CAPA’s, non-conforming product and Quality Cell Shutdowns.On-site corporate QA representative for internal and external audits.Responsible for overseeing environmental monitoring, incoming inspection, product release, calibration and validation activities.Responsible for developing, reviewing and approving work instructions, protocols, summary reports, and other documentation for all of CV.Responsible for ensuring effective failure investigations and implementation of effective preventative/corrective actions.Support and contribute to BU goals, metrics and performance measurement system. Be an active, contributing and engaged member of the Operations Leadership Team.Manages QA Coordinators and Quality Assurance Specialists
REQUIREMENTS
Job RequirementsBachelors Degree or equivalent combination of education and experience. Science/Engineering discipline is preferred.Prefer 2-5 years experience in Quality Engineering/Quality Systems; 1-3 years experience with manufacturing processes; ASQ Certified Quality Engineer or Quality Manager status;1 or more years supervisory experience; 1 or more year experience in FDA regulated industry, medical device manufacturer or tissue bank.Willingness to handle human tissue.