Inspector - Incoming

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).  It's 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 position will be responsible for planning, performing and documenting goods-in inspections and conducting a number of technical tests on finished product and incoming goods. This position will also be responsible for raising nonconformances and ensuring compliant practices at incoming inspection.

This role will report directly to the Sr. Product Quality Engineer and will be strongly aligned with the Operations/ Warehouse departments. 

This is an on-site role in our Oxford facility.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Sr. Product Quality Engineer the Inspector, Incoming will be responsible for:

• Maintaining 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.
• Help create incoming inspection procedures and work instructions and maintain and update related documents. 
• Help support implementation and improvements to incoming and inspection areas and other relevant documents.
• Maintaining traceability of incoming goods through SAP identification, visual management and quarantining. 
• Performing a number of technical tests and visual inspections on manufactured product to allow for quality release to Warehouse/Production/Service Centre.
• Assisting with non-conforming material investigations into component or device issues. 
• Act as Subject Matter Expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to incoming inspection. To include participating in and supporting external audits e.g BSI, FDA etc. 
• 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

Requirements

Skills & Experience

• Prior experience working in an incoming inspection area for medical devices required
• 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
• A good understanding of GMP compliance requirements in Quality Control
• Good attention to detail
• Demonstrates and promotes a collaborative working environment
• Understanding of using basic measurement tools (e.g. calipers)

Qualifications

• A degree in bioscience, engineering or equivalent or other 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.