|Job Ref:||EMP367120||Employer:||Matchtech Group plc.||Industry:||Medical & Pharmaceutical||Country:||United Kingdom||City:||Chipping Norton||Address:||Post Code:||OX7||Salary:||£30,000 - £37,000/year||Post Date:||14/10/2016 21:32|
Our clients have an exciting opportunity for a Quality Customer Controller to join their growing team to support key customers with all quality related activities.|
Experience working within a Quality based role within the Medical Device industry.
• Coordinate all quality activities and act as a single customer interface with Quality on site.
• Drive prompt investigation and resolution of quality issues and write investigation reports.
• Facilitate timely implementation of appropriate Exceptions (CAPA).
• Drive complaint investigations to ensure timely resolution.
• Support and host customer visits and deliver key information as requested by the customer.
• Liaise with customer to determine appropriate metrics, monitor data gathering and prepare reports for customer to meet required frequency.
• Work with other areas within QA (e.g. Labs) and across the business (e.g. Moulding, Assembly, Warehouse) to support improvements.
• Establish and maintain documented quality systems within the division which meet the requirements of 21 CFR part 820 and ISO13485, which are best practice and meet the needs of the business.
• Support management of customer audits and close out observations/actions through the completion of an evidence book.
• Report to management with regard to progress with activities and produce reports as required.
• Define and develop processes and procedures in area of expertise.
• Act as Subject Matter Expert for area of expertise by maintaining knowledge of regulations and awareness of regulatory expectations and customer requirements.
• Perform document reviews and approvals in area of responsibility.
• Perform any other duties as required by the Site Quality Assurance Manager.
Knowledge and Expertise Required:
• Lean Manufacturing Principles
• Managing continuous improvement projects
• Medical device manufacturing
• ISO 13485, GMP, cGMP, CFR 820
• Experience of quality management systems
• Ability to confidently deal with people of all levels
• Report and SOP writing skills