Quality Engineer

• Provide Quality support to the Manufacturing Operations Team
• Support CAPA & Issue Resolution to ensure timely and accurate completion
• Administer & support the deviation process to ensure timely and accurate completion
• Administer & support the quality notification process to ensure timely and accurate completion
• Prepare for supplier, customer, regulatory & notified body audits as required
• Conduct internal & supplier quality audits as required
• Support the change control process
• Prepare, review, and approve or reject quality related documentation
• Provide support for training in key aspects of the Quality Management System
• Generate quality related metrics, reports and KPI's and lead improvement projects and quality initiatives
• Participate in SQDIP meetings, provide accurate and timely reports, and take responsibility for the achievement of target KPI's for the role
• Actively use business systems such as CATSWEB, CERDAAC, SAP, Documentum & Learn4U
• Ensuring compliance with safety, health and environmental (SHE) legislation
• Driving a safety-first approach maintaining a zero-accident culture, ensure accident prevention and environmental protection regulations of the facility to assure a safe and productive working environment free of any liabilities or defects
• Engaging with project teams to help with selection, installation, and commissioning of new equipment

• Represent the business in customer audits and regulatory inspections to demonstrate that the client has compliant systems
• Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines
• 5 or more years' experience in a medical manufacturing environment or manufacturing environment
• In depth knowledge of Quality Management Systems, ISO 13485, 21 CFR 820
• IT literate with strong knowledge of Microsoft Office packages
• GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)
• Competent in the principles of and practical use of the Quality Management Systems

• You will be able to manage time effectively and possess a desire to succeed
• You will have a flexible approach and ability to adapt according to workload
• You are self-motivated, reliable, and able to work on own initiative
• You will be an effective team member and able to communicate across functions
• You will be curious - keen to understand, learn and try new things, and possess excellent written and oral communication skills

Flexible working hours