Job Description

• Quality representative for one or more departments within company providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
• Coordination of QA activities associated with customer feedback (including complaint) investigations as well as QMS changes; batch release; process validation and / or supplier monitoring to meet the wider business goals.
• Organize, host and facilitate risk management related activities and ensure compliance of such activities to the applicable standards and regulations.
• Management of quality personnel
• Monitoring of quality KPI’s and input to management review
• Execution of internal and supplier audits
• Support and input to external audits
• Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
• 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 ISO13485, FDA 21 CFR Part 820, MDSAP. Experience of working in a relevant role with a strong quality focus. Experience of post-launch IVD or medical device activities in a quality role. Scientific background. Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems). Self-starter. Specific relevant experience with a high level of knowledge in complaint investigation is essential. Excellent organizational skills for working on and prioritizing multiple activities. Ability to use problem-solving tools and methodologies. Ability to influence internal and external parties to maximize success. Good communication skills. Qualification to degree level. People management experience. Knowledge and experience of MDSAP. Trained auditor. Continual Improvement Training (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).