Job Title

Senior Quality Assurance Engineer Base salary 60,000 - 70,000, plus additional bonuses West Lothian area We are seeking a highly experienced and skilled Quality Assurance Engineer to join a leading medical device business as they expand their product globally. This role carries high responsibility, sitting directly beneath the site Head of Engineering. The business are a successful and rapidly growing medical device manufacturer. With a planned site expansion coming up, and approval for their product in the US within touching distance, they have a huge 2025 ahead. After identifying several areas for growth in the business, the Quality Assurance Team are under going expansion to account for this. As a brief synopsis, you will be responsible for managing key elements of the Quality Management System, Batch Release, and ensuring compliance to applicable standards across all levels of the business. Further Key Responsibilities: Oversee the Material Review Board and disposition productsA member of internal audit team - conducting process, product, and workplace auditsResponsibility for generating and reporting of quality KPIs to Site Head Manage the Customer Complaint handling through to resolutionPerform post-market surveillance planning and reportingProvide expert guidance and knowledge to technical and validation teamsProvide quality guidance on continuous improvement projects including change management, and risk assessments Lead regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standardsProvide support to management during notified body audits and subsequent closureKey Requirements Extensive experience within a QA role within a medical device, pharmaceutical or closely related industryBSc/BEng, or equivalent qualificationsStrong problem-solving abilityPrevious experience working in an aseptic manufacturing facility desirableThe ability to manage multiple stakeholder groups from operators to executive managementApply now by hitting 'Easy Apply' or email dion@entrustrs.com for more information!