Quality Engineer, Validation

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 fulfil 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 Quality Engineer, Validation is responsible for ensuring that manufacturing processes and test methods are robust, repeatable, and capable of consistently meeting defined requirements.

Working within the Product Quality team, the role leads process and test method validation activities across OrganOx and its suppliers. With a focus on providing Quality support for validation of new manufacturing processes (injection moulding, assembly, sterilisation, packaging), as well as sustaining existing processes at suppliers. It sits at the point where design intent is translated into controlled, reliable execution, in line with the principles of ISO 13485 and risk management expectations of ISO 14971.

By working closely with Design Assurance, Operations and Supplier the Validation Quality Engineer takes defined inputs, understands risk through tools such as pFMEA, and builds validation strategies that provide clear, objective evidence of performance. Validation activities are planned and executed in alignment with recognised guidance for process validation and measurement system analysis, ensuring outputs support design transfer and meet regulatory expectations.

The role requires a practical, disciplined approach. It involves writing Validation planning and reporting documents (VMP, VSR), support defining validation activities with IQ, OQ and PQ phases, analysing data, and producing outputs that withstand audit and regulatory scrutiny. The Validation Engineer is expected to operate with a degree of independence, bringing enough experience to move work forward with clarity and purpose from the outset.

This is an on-site position in Oxford, with flexibility.

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 Director, Product Quality, the Quality Engineer, Validation will be responsible for:

Validation Planning and Execution

• Develop and maintain validation plans aligned to product and process risk

• Lead execution of:

• Process validation (IQ, OQ, PQ)
• Test method validation (including MSA, Gage R&R, accuracy, precision)
• Ensure validation activities meet regulatory and internal quality requirements
• Define acceptance criteria based on risk, capability, and intended use

Design Assurance Interface

• Work closely with the Design Assurance team to:
• Understand design inputs, critical quality attributes, and intended use
• Translate design requirements into validation strategies
• Support design transfer by ensuring validation outputs are complete, clear, and usable

Risk Management

• Apply strong understanding of pFMEA to:
• Identify high-risk process steps and failure modes
• Ensure validation scope targets areas of unacceptable risk
• Use risk outputs to justify validation depth and sampling rationale

Supplier Validation

• Lead and support validation activities at supplier sites
• Review and approve supplier validation documentation
• Ensure alignment between OrganOx and supplier validation standards
• Provide guidance and oversight where supplier capability needs strengthening

Data Analysis and Reporting

• Use statistical tools to analyse validation data and demonstrate process capability
• Generate clear, structured validation reports with objective evidence
• Identify gaps and drive corrective actions where requirements are not met

Continuous Improvement

• Identify opportunities to improve validation approaches, efficiency, and robustness
• Support ongoing monitoring strategies for validated processes and test methods
• Contribute to strengthening validation procedures and standards across the business
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements:
Skills & Experience

Essential:

• Demonstrable experience in a process/test method validation role within a regulated industry (medical devices preferred)
• Practical experience of writing process validation (VMP/IQ/OQ/PQ/VSR) and test method validation (GR&R)
• Strong understanding of pFMEA and risk-based decision making
• Experience working with suppliers on technical or quality activities
• Ability to interpret technical requirements and translate them into structured validation plans
• Competent in statistical analysis (e.g. capability analysis, Gage R&R)
• Clear, disciplined approach to documentation and reporting

Desirable:

• Experience working in Quality within the medical device industry.
• ETO/gamma sterilization validation experience would be highly desirable
• Familiarity with ISO 13485, FDA 21 CFR Part 820 / 21 CFR Part 11 (where applicable)
• Background in Class II or Class III medical devices.
• Experience with domestic and international regulatory requirements and regulatory bodies.
• Ability to travel as required for project activities.

Qualifications

• A degree in bioscience, engineering, or a related technical field, or equivalent experience

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.