Find out more


Find out more


Quality Assurance and Regulatory Affairs Manager

An exciting opportunity has arisen within the Pillans Group working at Q Medical Technologies Ltd. Head office is based in Endmoor, however remote working could be considered for this role. The position will be full time 8.30am – 17.00pm, Monday to Friday.

Candidate profile:

Excellent interpersonal skills, you will be confident and able to communicate at all levels and have experience of team-working and working under pressure.

Required Competencies:

  • Project Management
  • ISO Management & Compilation
  • Quality and Regulatory Assurance Experience
  • ISO13485:2016 Experience
  • CE Trained
  • Technical file writing
  • Internal audit lead experience
  • Risk Management 14971 experience
  • MDR Compliance experience and knowledge

Preferred but not essential:

  • Biocompatibility
  • Clinical Trial Experience

What we offer

  • Competitive salary to be discussed depending on experience £40,000+
  • Company pension contribution
  • 25 days holiday plus bank holidays
  • Life assurance
  • Health insurance

Key Responsibilities

  • Manage and review quality systems to improve awareness, visibility, and communication on quality goals
  • Managing quality requirements for the business
    • Accountability for monitoring and maintenance of existing processes
    • Accountable for internal and external audits
    • Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
  • Managing the execution of Notified Body audits and track progress of responses
  • Accountable for investigating quality issues and interacting with products suppliers
  • Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
    • Authorising product release to stock and completion of relevant records upon receipt
  • Managing risk throughout Q Medical Technologies Ltd
    • Ensuring effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance
    • Managing new product registration, in line with commercial objectives
  • Writing technical files with the QARA Director
    • Organising clinical trials for new projects
    • Develop project proposal as required by the QARA Director
  • Supporting national tender account meetings
  • Working with the senior management team, representing head office
  • Supporting project managers with ongoing company projects Managing budgets for Q Medical.
  • Managing supplier meetings and contracts for Q Medical.
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