Quality Customer Controller

Introduction

Our client are a large Medical Device company based in Oxfordshire looking for a Quality Customer Controller

Important

Previous Quality experience working in the Medical Device industry

The Job

Key Responsibilities:
Coordinate all quality activities and act as a single customer interface with Quality.
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
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

Qualifications
Six Sigma – Green/Black Belt
Continuous Improvement
CQI Diploma in Quality (Member, Chartered Quality Professional -
MCQI CQP)
Highly computer literate e.g. Excel/Word and PowerPoint

Personal Characteristics
Effective team worker, equally able to work on their own
Excellent presentation skills
Highly self-motivated/self starter/resilient
Strong communication skills
Hands-on style
Build excellent relationships at all levels
Excellent time-management skills

To apply for this position, candidates must be eligible to live and work in the UK.