Inspector - Incoming in Oxford

ABOUT ORGANOX: OrganoX is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body, enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.

Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary: The position of Inspector, Incoming is responsible for performing product release inspection and testing of OrganOx medical devices. The role involves planning, performing, and documenting goods-in inspections and conducting a number of technical tests on finished product and incoming goods. The Inspector will raise nonconformances and ensure compliant practices at incoming inspection. This role reports directly to the Sr. Product Quality Engineer and is strongly aligned with the Operations/Warehouse departments. It is an on-site position at our Oxford facility.

Major Responsibilities:

• Maintain GDPR/cGMP compliance within the incoming inspection and quarantine areas through inspection of incoming goods against specifications.
• Execute incoming inspection protocols and test methods.
• Open nonconformances for incoming goods that fail inspection.
• Create and maintain incoming inspection procedures and work instructions, updating related documents.
• Maintain traceability of incoming goods through SAP identification, visual management and quarantining.
• Perform technical tests and visual inspections on manufactured product to allow for quality release to Warehouse/Production/Service Centre.
• Assist with non-conforming material investigations into component or device issues.
• Act as subject-matter expert for the area of expertise by maintaining knowledge of the relevant procedures and specifications related to incoming inspection, including participation in and support of external audits (e.g., BSI, FDA).
• Support and complete any other work-related tasks set by the Product Quality Engineering manager.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Skills & Experience:

• Prior experience working in an incoming inspection area for medical devices.
• Working knowledge of GDPR/cGMP requirements.
• Strong ability to create, write, and follow Standard Operating Procedures and Work Instructions/Specifications.
• Understanding of inspection criteria, use of drawings/specifications.
• Knowledge of SAP.
• Strong written and oral communication skills.
• Good understanding of GMP compliance requirements in Quality Control.
• Attention to detail.
• Demonstrates and promotes a collaborative working environment.
• Basic measurement tool proficiency (e.g., calipers).

Qualifications: A degree in bioscience, engineering or equivalent, or related field.

Benefits: At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation, race, or any other characteristics protected by law.