Design Control Quality Specialist

2 days left

Oxfordshire, England
Sep 29, 2016
Oct 27, 2016
Alex Langrish
Result Type
Position Type
Full Time

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.

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)

Apply for Design Control Quality Specialist

Already uploaded your resume? Sign in to apply instantly

All answers are required


Upload from your computer

Or import from cloud storage

Your Resume must be a .doc, .pdf, .docx, .rtf, and no bigger than 1Mb

4000 characters left

By applying for a job listed on Chem Jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.