|Job Ref:||EMP372327||Employer:||Matchtech Group plc.||Industry:||Medical & Pharmaceutical||Country:||United Kingdom||County/State:||Oxfordshire||City:||Oxford||Address:||Post Code:||OX4||Salary:||£25,000 - £28,000/year||Post Date:||22/10/2016 21:31|
My client is a global industry leader in medical device design and manufacturing. They pioneering medical products for the world’s leading pharmaceutical and diagnostic companies and they are currently looking for a Design Control Quality Specialist to join their team in Oxfordshire.|
Degree level education in scientific discipline and current knowledge of regulatory requirements for medical device
The role of the Design Control Quality Specialist is to work in partnership with associates in Research & Development plus the customer (as applicable) to ensure projects comply with all requirements of Design Controls (to include CFR Part 820).
The role is key to provide Quality oversight, input and guidance on a number of projects to include:
Key responsibilities and accountabilities:
• Responsible for verifying compliance to quality and regulatory requirements for device development and design control
• Responsible for providing quality and compliance guidance to associates in Research & Development and in Industrialisation/Operations
• Primarily responsible for all quality aspects for development projects and design control with key customer(s)
• Provide quality input during development and design control phases of projects in meetings, supplier visits and observing within production.
• Review and approve device development for both new devices undergoing development and for existing devices undergoing continuous improvement
• Review and approval of qualification/validation protocols and qualification/validation reports for tools, equipment, facilities, utilities, test methods and computerised systems for the industrialisation of products and processes
• Interface with auditors (external and internal) to confidently present processes and records to demonstrate quality compliance
• Work with managers and SME’s to assist investigation and close out of any related Corrective and Preventive Actions (CAPAs) arising from either internal or external audits in area of responsibility
• Report to DDI Quality Manager on progress with activities, provision of metrics and other information (e.g. input to Monthly Business Reports, Quarterly Reports) to identify trends/ areas of opportunity for improvement and escalation of issues
• Establish and maintain familiarity with current Best Practice in quality compliance aspects of device development and design control
Key Knowledge and Expertise
• Sound knowledge of current regulatory requirements for medical device (alternatively pharmaceutical) development and design control
• Knowledge of validation as well as experience with Best Practice (preferable)
• Proven experience working in medical devices.
• Knowledge of Current Good Manufacturing Practices (cGMP) requirements.
• Strong verbal and written communication skills.
• Excellent listening, observing and questioning skills.
• Experienced using Microsoft Office, including PowerPoint, Excel and Word
• Degree level education in scientific discipline (or equivalent experience)