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Randstad Logo Randstad · IT - Software Development

Q&RA Engineer II

United Kingdom, Basingstoke 27.00 GBP / Hour · Job Posted June 09, 2026
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Job Description

Quality & Regulatory Affairs (Q&RA) Engineer II Location: Basingstoke (Remote with 1x month on-site meeting attendance required) Pay Rate: £27.00 per hour Contract Duration: 9 months initially (40 hours per week) Start Date: ASAP Position Overview Are you looking to take the next step in your quality career and make a lasting impact on a global scale? We are seeking a high-performing Q&RA Engineer II to join our team. In this role, you will play a vital part in ensuring quality compliance across our operations, helping to deliver life-changing products that make the world healthier, cleaner, and safer. As a Quality Engineer, you will provide critical quality oversight through detailed documentation reviews, process monitoring, and close cross-functional collaboration. This position is ideal for an experienced professional looking to champion compliance, lead major quality investigations, and drive continuous improvement initiatives.

Job Responsibility

  • Compliance & Audits: Support and maintain robust compliance with GMP/GxP, ISO, and global regulatory requirements. Conduct and support both internal and external audits and regulatory inspections
  • Investigations & CAPA: Investigate complex quality issues, lead root-cause analysis efforts, and collaborate across departments to drive effective corrective and preventive actions (CAPA)
  • Documentation & Change Control: Author, review, and approve critical quality documentation (including SOPs and investigation reports) and manage change control activities
  • Data & Metrics: Perform advanced data analysis, trending, and reporting of quality metrics to support system enhancements and continuous improvement initiatives

Requirements

  • Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of experience in QA/QC OR an Advanced degree with 3+ years of relevant experience
  • Proven background working in highly regulated industries (Pharmaceutical, Medical Device, or Biotech preferred)
  • Comprehensive experience with Enterprise Quality Management Systems (EQMS), Document Control Systems, CAPA processes, deviation management, and change control
  • Demonstrated expertise in advanced root cause analysis, investigation techniques, and corrective action implementation
  • Experience actively conducting and hosting internal/external audits and regulatory inspections
  • Strong proficiency in statistical analysis, data trending, and quality metrics reporting
  • Project management experience is highly preferred
  • Deep knowledge of GMP/GxP regulations, ISO standards (such as 9001 and 13485), and other relevant quality system requirements
  • Strong grasp of risk assessment methodologies and continuous improvement tools
  • Advanced technical writing skills for authoring precise SOPs and investigation reports
  • Exceptional problem-solving abilities, high attention to detail, and strong interpersonal/communication skills
  • Ability to work independently, guide cross-functional teams, and work in manufacturing environments with appropriate PPE as needed
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