Company Description Tissue Regenix Group is a leading medical devices company specializing in regenerative medicine, originally spun out from the University of Leeds in 2006. Its patented dCELL® decellularisation technology produces acellular tissue scaffolds that support the repair of diseased or damaged body parts without triggering rejection, with applications in sports medicine, heart valve replacement, and wound care. The Group has expanded internationally with TRX BioSurgery in the United States and the GBM-V multi-tissue bank in Germany. The acquisition of CellRight Technologies® further strengthened its portfolio of osteobiologics and wound care products used across spine, trauma, orthopedic, dental, and sports medicine procedures. Tissue Regenix continues to grow its global network and collaborates closely with healthcare professionals, distributors, and partners.
Role Description A hands-on role in a small operations team, combining medical device manufacture with leading investigations, CAPA, improvements and approved changes, including new product variants, to keep manufacturing reliable, efficient and compliant.
Key responsibilities
Manufacturing:
Carry out production work, including tissue dissection, pre-treatment, processing, packing, distribution, incoming inspection, media manufacture and cleaning. Some off-site work may be required. Coordinate outsourced packing, irradiation and testing.
Nonconformance and CAPA:
Lead root-cause investigations into deviations and recurring issues. Agree, implement and check corrective actions, and escalate significant risks and trends.
Identify and lead improvements to quality, efficiency, reliability and cost, using data and structured problem-solving.
Change management:
Implement approved process changes and new product variants into routine production, covering documentation, materials, equipment and readiness, with records kept.
Operations and materials:
Coordinate production and distribution with the Production Manager, manage stock and purchasing needs, and resolve supply or capacity constraints.
Quality and compliance
Keep accurate records and controlled documents, contribute to procedures, risk and COSHH assessments, and work to ISO 13485 and health and safety requirements.
Person specification
Hands-on manufacturing experience in medical devices or another regulated industry
Experience working under ISO 13485 or an equivalent quality system
Proven ability to investigate issues independently, find root causes and drive corrective actions to completion
Organised, proactive and flexible, happy to do routine production alongside technical work
Strong written and verbal communication, and good Word and Excel skills
High accuracy and attention to detail; works well alone and in a small team
Degree in biological sciences, engineering or related field, or equivalent experience
Experience in biological medical device or tissue processing manufacture, and of GMP
Experience leading CAPA, process changes or new product introductions
Experience coordinating subcontractors or test labs, and of project management or CI methods
Knowledge of medical device regulations, design control, process validation or manufacturing transferm
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