Quality Analyst

About the role

We are seeking a Quality Analyst to join STERIS and ensure product quality, regulatory compliance, and continuous improvement across our operations. This hands‑on role is based on the plant floor, leading investigations, root‑cause analysis and corrective actions in a highly regulated environment.

Key responsibilities

• Lead and manage non‑conformance 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 QMS programs such as CAPA, complaints handling, calibration, supplier quality, document control, validation and risk management.

Required profile

• Degree or diploma in Science, Life Sciences or a related technical field.
• 3–5 years of experience in a regulated environment.
• Strong knowledge of quality systems, GMP and ISO standards (e.g., ISO 13485, ISO 11137, FDA 21 CFR Part 820/211, EU GMP).
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Valid driver’s licence and own transport.
• Excellent written and verbal communication skills.
• Ability to work independently and within cross‑functional teams in a fast‑paced, highly regulated setting.

Required skills

• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint
• Statistical analysis of quality data