Job Purpose:Fulfil quality assurance responsibilities for new product development and post-market activities within the sustaining engineering team (i.e. commercial product support), including:Demonstrating and promoting a commitment to improving patient safety, customer satisfaction, and product quality.Understanding and complying with the organisation's quality, business, and health & safety systems, as well as applicable market and legal regulations governing quality systems.Identifying, removing, or mitigating risks associated with the design, use, and manufacture of medical devices.Ensuring commitment to required training and understanding and complying with all regulations governing assigned work.Key Responsibilities:GeneralCompletes work assignments under limited supervision and guidance.Interfaces with cross-functional teams including R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres, and Post-Market Quality Assurance, providing technical and quality systems input.Demonstrates familiarity with requirements and procedures governing medical device Design Control, Risk Management, and Post-Market Surveillance.Identifies and resolves complex exceptions within work assignments.Supports continuous improvement in product and process quality.Builds quality into all aspects of work by maintaining compliance with all quality requirements.Demonstrates excellent interpersonal and communication skills, with strong leadership capabilities.TechnicalProvides both quality and technical input to post-market commercial product activities.Experienced in post-market (complaints) support, risk management, design and process change, and standards compliance with regulatory requirements.Provides design quality support in the resolution of product investigation reports (PIRs), complaint investigations, CAPAs, vigilance issues, and regulatory requirement changes.Demonstrates excellent analytical and problem-solving abilities.Analyses data, draws conclusions, and makes appropriate decisions based on risk management activities and test data.LeadershipActs as an active team member, completing quality deliverables associated with sustaining engineering and post-market support activities.Uses project assignments as opportunities to develop self and others.Demonstrates strong motivation and consistently applies best practices in line with agreed objectives.Willingly implements changes within project and departmental practices.Supports a culture of continuous improvement and constructive challenge to achieve best-in-class performance.Qualifications & Experience:HETAC Level credits) qualification in a STEM discipline, with a minimum of 3–4 years' experience in a similar role.Strong technical capability, communication skills, teamwork abilities, and initiative.Proven ability to work effectively both as part of a team and independently, with minimal supervision.