Job Description

• Providing quality advice and support to other departments within the organization
• QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues
• QA review of records associated with commercial and/or validation batches including the collation and archiving of all relevant batch records as part of Device History Records
• Update and maintain Device Master Records
• Execution of internal audits
• Collation and provision of data for external audits
• Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
• Collation of data to support the generation of Quality Metrics and KPI’s
• Support supplier approval and monitoring activities including supplier audits
• Prepare and create documents and records for upload on to the document management system
• Review and approve change controls as Quality representative on project teams and QMS

Required Knowledge, Skills, and Abilities

Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry. Experience of working in a relevant role with a strong quality focus, experience working in complaints is highly desirable. Scientific background. Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (e.g. document management; complaint; ERP systems). Excellent attention to detail. Good team worker. Excellent organizational skills for working on and prioritizing multiple activities. Ability to use problem-solving tools and methodologies. Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP. Experience of post-launch IVD or medical device activities in a quality role. Degree preferred. Trained auditor. Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).