Operations Engineer

Tissue Regenix Group; Garforth; In loco; GBP 32.000 - 42.000; Tempo pieno

Descrizione del lavoro

Tissue Regenix Group is a leading medical devices company focused on regenerative medicine. The role sits in a small operations team, blending manufacturing with investigations, CAPA, and continuous improvement to keep production reliable and compliant.

You will lead root-cause analyses, implement corrective actions, and drive changes across processes, materials and documentation within an ISO 13485 framework. A degree in a related field supports the hands-on regulatory environment.

Competenze

• Hands-on manufacturing experience in medical devices or regulated industry.
• Experience with ISO 13485 or equivalent quality system.
• Proven ability to investigate issues and drive corrective actions to completion.
• Organised, proactive and flexible with attention to detail.
• Experience coordinating subcontractors or test labs, and project management/CI methods.

Mansioni

• Manufacturing: perform tissue dissection, pre-treatment, processing, packing, distribution, inspection, media manufacture and cleaning; coordinate outsourced packing, irradiation and testing.
• Lead root-cause investigations into deviations; implement corrective actions and monitor for trends.
• Identify and lead improvements to quality, efficiency, reliability and cost using data and problem-solving.
• Change management: implement approved process changes and new product variants with proper documentation and readiness.
• Coordinate production and distribution with Production Manager; manage stock and purchasing needs; resolve supply constraints.
• Keep records and controlled documents; contribute to procedures, risk and COSHH assessments; work to ISO 13485 and safety requirements.

Conoscenze

Root cause analysis

CAPA handling

Process improvement

Communication

Formazione

Biological sciences / Engineering degree

Strumenti

Excel

Word

Descrizione del lavoro

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