QUALITY ENGINEER/VALIDATION SPECIALIST

My client are seeking a Quality Engineer/Validation Specialist for up to a 6-month term contract to support automation machine validation in an ISO 13485 environment. The role requires hands-on experience in developing and executing IQ, OQ, and PQ protocols, and close collaboration with QC and production teams to ensure compliance and continuous improvement. Proven experience within the medical, technological, or food industry in a similar environment.

Validation & Quality

* Develop and execute Installation Qualification (IQ) protocols to ensure equipment is installed and utilities are connected per user requirements, design specifications, manufacturer's instructions, and Good Manufacturing Practice (GMP).

* Design and perform Operational Qualification (OQ) protocols to demonstrate equipment and processes consistently produce acceptable results. Establishing and documenting process parameter limits based on manufacturer's specifications and production requirements. Operate equipment at the extremes of normal production conditions to simulate actual manufacturing scenarios.

* Conduct Performance Qualification (PQ) protocols to confirm equipment and processes perform effectively during routine production.

Desired experience

* Experience in ISO 13485 regulated environments.

* Expertise in automation machine validation.

* Hands-on experience creating and executing IQ, OQ, PQ protocols.

Salary: £20-£25 Per Hour - £41,000-£52,000