QARA/QMS Specialist – Recruitment brief

Job title: QARA/QMS Specialist

Responsible to: QARA/QMS Manager

A new opportunity has arisen in our QARA team. Your job will be to support the QMS Manager with the implementation of an effective Quality Management System, driving company compliance with Quality and Regulatory requirements whilst also streamlining and simplifying processes. You will assist in the reporting on the health of the QMS to the Senior Management Team and drive a continuous improvement culture across the company.

With a reputation for innovation and a trusted name, Raynerare the only manufacturer of intraocular lenses in the UK, selling to over 70 countries globally. Our products have restored sight to millions of people worldwide and we are at an exciting stage of new investment and development of our business and people.

Key responsibilities:

  • Assist in the maintenance, administration and execution of the Change Control System
  • Support the QMS Manager in establishing and maintaining standard operating procedures for document development, management and control
  • This includes all documents associated with Quality Systems, such as the Quality Manual, Corporate and facility requirements, manufacturing and quality specifications, Device Master Records, and documentation related to Quality System training
  • Support other teams in the creation and maintenance of Quality Management or equivalent System related procedures, records and work instructions, as required
  • Assist with internal and external audits as either audit lead or support as required by the QMS Manager
  • Assist in process development to streamline and simplify Quality Management and associated systems
  • Assist in the identification, management and completion of Corrective and Preventive Actions with a commitment to continuous improvement
  • Undertake archiving of company material, ensuring an efficient system which is easily accessed and utilised in line with the relevant procedures

Skills and Experience:

  • Experience working with Quality Management Systems
  • Experience working in Quality Assurance
  • Experience in Auditing (External and Internal)
  • Very good working knowledge of ISO 13485
  • Preferably knowledge of CFR820
  • Degree in relevant discipline (Science/Engineering) or equivalent

Personal skills:

  • Good knowledge of the regulatory environment and quality systems
  • Understanding of manufacturing systems
  • Excellent communication skills
  • Team player
  • Flexible approach to workload
  • Able to operate in a rapidly changing environment and be able to balance multiple priorities simultaneously
  • Attention to detail
  • Advanced Excel, Word and Adobe skills
  • Excellent written English

December2015 – Rayner IOL