Quality Assurance Analyst / Quality Assurance

Henfield, £23,000 - £30,000 Permanent
Reference: P8JOB4983 | Specialist area: Quality Management | Sector: Manufacturing

My Client is passionate about their work, customers, people and our culture. Already a world-leading manufacturer and supplier of instrumentation and software to the Life Science Industry, they are continually striving to be the very best at what we do through delivering the highest quality products and an exceptional service.

The Role

Already operating a quality system, they are seeking a Quality Assurance Specialist to take them forward as they continue to grow. In this position you will have support of other Quality Assurance / Regulatory members within the organisation and report to the Group Quality Director based at Sheffield. However, you will be responsible for managing and developing the Quality function at their offices in Henfield. You will be an essential member of the team, embodying the organisation’s quality culture, training, and coaching staff as appropriate, ensuring compliance to customer, industry, and regulatory requirements, including ISO. This role would suit you if you’re looking to progress your Quality Analyst role or someone already in a managerial position.

Your role will be essential in making sure that the medical devices produced conform to regulatory requirements whilst maintaining their ISO and regulatory accreditation. Additionally, the role will look to promote a continuous improvement culture within the business, assisting all departments with the creation of procedures and all associated documentation.

Responsibilities

Your main responsibilities will be:

Compliance

  • Ensuring that all products comply with ISO 9001, ISO13485, MDSAP and MDR and regulatory requirements.
  • Depending on your experience, the role will include managing and maintaining the internal audit
  • process, including conducting internal audits on all company processes.
  • Managing the Non-Conformance process for the organisation.
  • Improvement and change management
  • Through the running of the QMS driving forward improvements to working processes.
  • Implementing and managing change control

Requirements

Essential

  • Previous experience within quality assurance
  • Personal attributes:
  • Excellent communication skills
  • Reliable
  • Organised
  • Pragmatic
  • Able to work under pressure and adhere to tight timelines whilst still delivering quality results
  • Attention to detail

Desirable

  • Understanding of ISO9001, 13485, and MDSAP and MDR.
  • Experience of working with Medical Devices
  • Previous experience of conducting audits
  • Degree (or similar) in a relevant course
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