Takes a preventive approach to Quality Assurance, proactively identifying potential issues. Uses strong organisational skills and effective time management to ensure work is completed in a timely manner. Effectively prioritises workload to ensure timely completion of critical tasks. Plans and executes daily tasks to ensure timelines are met. Takes a pragmatic and logical approach to challenges faced. Explains technical topics clearly to diverse stakeholders through effective communication. Promotes a culture of continuous improvement through reflection and factoring in previous learnings. Makes informed decisions related to product quality, including dispositioning non-conforming product. Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques. Completes timely scoping and containment of product-related issues when required. Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation. Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances. Familiar with BSC Quality Systems and ISO/MDD/MDR standards. Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert. Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation. Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver. Maintains relationships and gives technical guidance to Quality Technicians. Deals with suppliers, other engineering disciplines within and outside of the site as required. A Level 8 Degree (240 Credits) or equivalent in a STEM discipline. A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.