Quality Assurance Co-Ordinator (Auditor, Quality Control) KIML81912

Quality Assurance Co-Ordinator

Our client is looking to appoint a Quality Assurance Co-Ordinator who will support the Quality Manager in the maintenance and continual compliance of the Quality Management System throughout the company, ensuring the best possible products and services are provided to the customer.

Key Responsibilities

• Support in the monitoring and review all company processes, in conjunction with the Quality Manager in order to ensure continual compliance to the relevant regulations and standards and that there is a process of continual improvement
• Monitor and drive improvements using CAPA activity across all areas of the business
• Carry out the duties and responsibilities as defined in ISO 13485 and ISO14001
• Conduct Quality Audits within all manufacturing areas in line with company procedures
• Maintaining all QMS Quality Policies, Procedures and Operating Instructions
• Provide back up to Vigilance executive ensuring all product complaints are processed in line with group procedures and department KPI's
• Preparation and reporting of monthly Quality Metrics 
• Help drive internal product improvements
• Other duties as necessary to support the operations of the Quality and Regulatory Department including:

Assist with validation studies on equipment and processes and assist with evaluation of new components reporting relevant data to management

Assist with testing programmes for items such as needles, high pressure tubing and catheters etc.

Experience Required

• Previous experience in a Quality environment (ISO13485 is preferred)
• Knowledge of Medical Device Manufacturing
• Knowledge of Auditing preferred
• Good Manufacturing Practice (GMP) experience preferred
• Broad knowledge of quality systems and procedures is preferred

Skills and Abilities

• Well organised – able to manage a complex workload
• Ability to deliver to tight deadlines
• Pro-active, able to work independently and with initiative
• Ability to gather information from various systems / stakeholders / sources
• Excellent problem solving skills
• Well-developed IT skills and competencies
• Strong attention to detail and customer focus
• Excellent verbal and written communication skills
• Have the drive for performance, be self-confidence with the ability to influence others

This is a Blue Octopus Recruitment Ltd vacancy who are operating as an employment agency. Once you have clicked to apply for this vacancy, we will then send you more information on the role including a copy of the application form via email