Quality Analyst

About the Role

We are looking for a Quality Analyst to join our team and play a key role in ensuring product quality, regulatory compliance, and continuous improvement across our operations.

This is a hands-on, operational role, with strong presence on the plant floor. You will lead investigations, drive root cause analysis, and implement corrective actions, ensuring that all processes comply with applicable standards including ISO 13485, FDA 21 CFR Part 820/211, EU GMP and ISO 11137.

Key Responsibilities

• Lead and manage nonconformance investigations, including customer-facing issues and communication
• Execute product and report release for processing runs involving deviations
• Drive root cause analysis and ensure effective CAPA implementation
• Support and manage internal audit remediation activities
• Develop and maintain quality system policies, procedures, and documentation
• Analyze quality data using statistical techniques and recommend improvements
• Monitor, track, and report on quality performance metrics
• Provide guidance and training to colleagues on quality principles and continuous improvement
• Collaborate cross-functionally to embed quality in daily operations
• Lead and support key QMS programs, including:
  • CAPA
  • Complaints handling
  • Calibration and maintenance
  • Supplier quality
  • Document and change control
  • Validation and risk management
• Ensure compliance with customer specifications and regulatory requirements, including audits, dosimetry, validations, and reporting

Minimum Requirements

• Degree or diploma in Science, Life Sciences, or relevant technical field
• 3–5 years’ experience in a regulated environment
• Strong knowledge of quality systems, GMP, and ISO standards
• Experience with quality data analysis and reporting
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Valid driver’s license and own transport
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work both independently and within cross-functional teams
• Comfortable working in a fast-paced, highly regulated environment

Preferred Qualifications

• Experience in medical device or pharmaceutical industry
• Working knowledge of ISO 13485 and GMP environments
• Exposure to sterilisation processes or gamma technology
• Training in Total Quality Management (TQM) or similar

Key Competencies

• Strong ownership and accountability
• Attention to detail and compliance mindset
• Data-driven decision making
• Continuous improvement focus
• Ability to influence and collaborate across teams