QA Software Engineer (MES)
- Contract Length: Initial 12-month contract
- Location: Witney
- Salary: Up to £57,000 per annum (dependent on experience)
Role Overview
In this role, you will act as the crucial bridge between our shop floor and quality management systems for a leading Global Medical Device technology company. You will be responsible for maintaining, updating, improving, and building our MES platforms, ensuring that the software tracking our medical device production is robust, validated, and compliant with strict industry regulations.
Core Responsibilities- System Development & Enhancement: Build, maintain, update, and continuously improve workflows, recipes, and digital batch records within our MES platforms to align with precise medical device product specifications.
- Programming & Data Integration: Utilize C# and SQL to maintain system integrity, develop backend updates, manage databases, and optimize the data flow between higher-level enterprise systems (ERP) and shop-floor equipment.
- Compliance & Software Validation: Ensure all MES modifications strictly meet medical device regulatory standards (e.g., cGMP, ISO 13485). Draft, update, and execute rigorous validation protocols and software test scripts.
- Quality Assurance & Defect Tracking: Monitor work-in-progress (WIP) systems in real-time to proactively catch software deviations, generate non-conformance reports, and enforce corrective/preventive actions (CAPA).
- Cross-functional Collaboration: Work closely with manufacturing, IT/OT infrastructure, and quality assurance teams to ensure seamless system operation and minimal downtime.
Technical Skills & Experience
- MES Expertise: Proven, hands-on experience working directly with MES systems (e.g., Siemens Opcenter, Critical Manufacturing, Werum PAS-X, Camstar, or similar platforms).
- Strong Programming Skills: Direct, practical programming experience using C# and writing efficient SQL queries for database management and system integration.
- Regulated Industry Background: Prior experience working within a highly regulated sector is ideal, but not essential, with a strong preference for Medical Devices, Pharmaceuticals, or Aerospace.
Education & Soft Skills
- Education: A Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline.
- Methodical Mindset: Sharp attention to detail with a passion for software quality assurance, validation, and automated/manual testing processes.
- Communication: Excellent communication skills to effectively collaborate with both factory floor operators and senior engineering teams.
Randstad Business Support is acting as an Employment Business in relation to this vacancy.
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