Do you want to work for and make a real impact on a £130m turnover, private equity backed, international healthcare business, which specialises in the development, manufacture and distribution of diagnostic products which has doubled its revenues in the last 5 years?
As a Quality Engineer with The Binding Site, you will work within the QA team located in manufacturing to ensure the company maintains compliance to external and internal quality system requirements (ISO9001/13485, FDA CFR 820 part 21, QSR's etc)
You will work alongside manufacturing teams and advise on quality related day to day issues. The Quality Engineer in manufacturing is responsible for assuring that manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product.
Reporting to a Quality Engineering Lead, the Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved metrics such as Overall Equipment Effectiveness (OEE), Scrap reduction and ability to leverage increased quality for delivery performance improvements, etc.
You will also receive full Training in the following:
• 13485 regulations
• FDA part 820 regulations
• Internal IFS modules
• Change control
• Root Cause Analysis
• Risk Assessment
• Meeting skills
• Time management
• Effective communication
• Team profiling
• Lean Six Sigma
• Microsoft packages
• A level or equivalent
• Experience of NCR/CAPA
• Experience of working within QA Engineering or manufacturing QA position in a manufacturing environment within the IVD or Medical Device Industry/ or regulatory industry
• Strong communication skills both written and verbal.
• Good understanding for Quality principles / Quality systems.
• Experience of non-conforming product and corrective action processes.
• Problem solver.
• Degree or equivalent in Biological sciences or similar
• Working knowledge of FDA part 820, ISO 13485
• Quality Assurance/ manufacturing engineering background
• Working knowledge/experience of PFMEA,
• Risk management to ISO 14791.
• Experience in validation.
• Knowledge quality tools.