Quality Assurance Coordinator

Bedford

£20,000-25,000

Consumer Healthcare / Medical 

This is a good opportunity for someone with a previous 1-2 years career experience within Quality Assurance / Documentation / Administration and who has worked within a regulated and compliance driven industry to join a reputable and well-known manufacturer of consumer healthcare and medical products. 

The role as Quality Assurance Coordinator will be supporting the Quality Assurance department in managing the documentation and reporting of data to ensure that their quality management system is accurate and compliant to ISO 13485.

This the opportunity to join a supportive QA department where you will be given the tools and support to develop your career within Quality Assurance quickly.

The position of Quality Assurance Coordinator is ideal for some who has performed similar Quality Assurance responsibilities- ideally already within healthcare / medical devices / pharmaceuticals or maybe has come from within the NHS or Public Sector organisation or for instance banking and finance regulatory fields.

Quality Assurance purpose:

This role has accountability for supporting the Electronic Document Management system (EDMS)- which generates quality data to assist with monitoring the performance of the company's products and the accuracy of the Quality Management System (QMS) and escalating identified trends or non-conformance to the Quality System Manager.

As Quality Assurance Coordinator you will be the point of contact for related EDMS matters including training of its users. 

The overall goal of the role is to assist with meeting business needs and maintaining the Quality Management System to world wide compliance standards such as ISO 13485.

Main Responsibilities

• Electronic Document Management System:
  • Oversight & Coordination of the EDMS
  • EDMS Trainer
  • Tracking EDMS tasks to completion to achieve timely compliance
  • Assisting with the generation of Key Performance Indicators (KPI’s) ensuring that associated reporting timelines are achieved
  • Tracking and reviewing KPI’s for trends and/or Non-Conformance to monitor the effectiveness of the QMS whilst identifying opportunities for improvement
• Quality System Processes
  • Monitoring & Coordinating Quality System processes to ensure tasks are completed on time and escalating any issues found. These tasks may include:
    • Internal Audits
    • Management Review
    • Non-Conformance closure
    • CAPA investigations closure
• General Responsibilities
  • Supporting Internal Audit planning
  • Conducting internal audits as part of an audit team
  • Support of all external audits
  • Preparing and delivering Quality System Training

Furthermore the role requires a good communicator and someone who will enjoy a position where you will be communication with multiple people and departments within the business on a daily basis.

Experience and Skills required:

• Knowledge or experience of working in a regulated environment or industry.
• Competency with Microsoft Office tools
• Proven ability to apply numerical reasoning and ability to report findings
• The ability to build relationships with internal staff both within your department and other areas of the business.
• Act as a key contact for external parties and customers

If you are interested in this Quality Assurance opportunity please contact James Powell here at TXM Recruit.

TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.