Senior Quality Specialist

Location: Wellingborough, England, United Kingdom
Salary: £40000 - £50000 per annum + + benefits
Job Type: Permanent
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Our client is a fast growing manufacturer of PPE/RPE products. They are experiencing a period of rapid growth and our need of a Senior Quality Specialist in the team reporting to the Head of Quality.

The Senior Quality Specialist will be responsible for the following;

  • PPE testing and technical files.
  • Liaising with Notified bodies as required ensuring that Notified Body non-conformities are minimised.
  • The Senior Quality Specialist will complete activities to ensure compliance with ISO 13485 and maintenance / improvement of the company's Quality Management System (QMS).
  • Supporting the Quality Manager with general administration.
  • Promote Quality, Quality Management Systems and Good Manufacturing Practice (GMP) awareness at all levels of the business
  • Work closely with other key departments within the business to support and advise on good working practices in line with the requirements of applicable PPE / medical device legislation.
  • The Senior Quality Specialist will promote the Company's purpose and vision and ownership of its values and strategic objectives

Principal Accountabilities:

  • The Senior Quality Specialist will ensure technical files are collated and updated when required.
  • Arrange required testing and review test reports.
  • Assist with the validation of sterilisation and packaging processes.
  • Carry out QC inspections and checking samples coming as required.
  • Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframe.
  • Responsible for Notified Body Audits/External Audits.
  • Complete internal audits as required.
  • The Senior Quality Specialist will assist with the creation and control of quality documents and quality records (Quality Manual, Procedures, forms etc).
  • Assist with the creation of procedures (SOPs) and work instructions for all departments.
  • Assist with the monitoring, measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised. General:
  • To assist with the Company's future strategy and direction of maintaining a first-class manufacturing capability and helping to build on its continuous process improvement programme.
  • Understand H&S Regulations.
  • Responsible for self-development and to participate in the company's performance development process

Education:

  • Either degree qualified or proven practical record in quality assurance
  • Ideally knowledge of PPE/RPE or at least medical device QA processes

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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