Medical Device Ops Engineer: CAPA & Process

Tissue Regenix Group; Garforth; On-site; GBP 32,000 - 42,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Root cause analysis

CAPA handling

Process improvement

Communication

Education

Biological sciences / Engineering degree

Tools

Excel

Word

Job description

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.