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Quality Manager, Regulatory Medical Devices job in Kendal at Recruitment Helpline

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Quality Manager, Regulatory Medical Devices at Recruitment Helpline

Quality Manager, Regulatory Medical Devices

Recruitment Helpline Kendal, Cumbria Full Time
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An Excellent opportunity for an Experienced Quality Manager, Regulatory Medical Devices to join a well-established company.

 

The position is based at their Head Office in Endmoor however remote working could be considered for this role.  The position will be full time 8.30am - 17.00pm, Monday to Friday.

Key Required Competencies

  • Project Management
  • Minimum of three years regulatory experience
  • 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
  • Experience with the FDA

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 regarding these
  • 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

What we offer

  • Competitive salary plus great benefits
  • Company pension contribution
  • 25 days holiday plus bank holidays
  • Life assurance
  • Health insurance

Employment Type

 

Full-time




.

Recommended Skills

Quality Management
Auditing
Management
Software Packaging
Corrective And Preventive Action (Capa)
Iso 13485 Standard

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