OrganOx
Healthcare
QualityEngineer,Validation
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Engineer, Validation at OrganOx. Skills: Process validation, Test method validation, Risk management. Develop validation plans. Maintain validation plans”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Process/test method validation role, Writing process validation, Writing test method validation, Understanding of pFMEA, Risk-based decision making, Working with suppliers, Interpret technical requirements, Translate requirements to validation plans, Competent in statistical analysis, Clear, disciplined documentation, Clear, disciplined reporting
Nice to Have
Quality in medical device industry, ETO/gamma sterilization validation, Familiarity with ISO 13485, Familiarity with FDA 21 CFR Part 820, Familiarity with 21 CFR Part 11, Class II or Class III devices, Domestic regulatory requirements, International regulatory requirements, Travel as required
What You'll Do.
Develop validation plans
Maintain validation plans
Lead process validation
Lead test method validation
Define acceptance criteria
Understand design inputs
Understand critical quality attributes
Understand intended use
Translate design requirements
Support design transfer
Identify high-risk process steps
Identify failure modes
Ensure validation scope targets risk
Justify validation depth
Justify sampling rationale
Lead supplier validation
Support supplier validation
Review supplier documentation
Approve supplier documentation
Align OrganOx and supplier standards
Provide guidance to suppliers
Oversight supplier capability
Analyse validation data
Demonstrate process capability
Generate validation reports
Drive corrective actions
Identify opportunities to improve validation
Support ongoing monitoring
Contribute to strengthening validation procedures
Contribute to strengthening validation standards
Adhere to Code of Conduct
Adhere to company policies
How You'll Work.
Team & Collaboration
Product Quality team; Design Assurance team; Operations team; Supplier teams
Full Job Description
**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
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