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Quality Assurance Compliance Specialist

  • Location
  • Sector
  • Salary/Rate
    £30,000 - £35,000 +Excellent Benefits
  • Salary Frequency
    Year
  • Reference
    5668KS

Job Description

Quality Assurance Compliance Specialist

Salary: £30,000 - £35,000 +Excellent Benefits

8:00 am-4:30 pm

The role is a standalone role with no direct reports, allowing flexibility on hours and some work from home.

Company Information:

My client is a leading organisation that supply various products to the care sector. They are a growing business looking to recruit a Quality Assurance Compliance Specialist to join their team on a permanent basis.

The Quality Assurance Compliance Specialist will be responsible for ensuring that documents meet the organization’s needs and meet regulatory requirements for medical devices.

The role will support the creation of regulatory submissions, PMS and Technical Files and/or updating documents, and actively participate in the creation, implementation, and continuous improvement of the quality management system, including developing and maintaining quality systems and processes.

The role will also supply additional QC and H&S support to the operations department where required. It will involve tasks to support the continuous improvement of internal quality processes, general H&S activities.

Key Responsibilities

  • Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including ISO 13485, ISO 9001 and other standards.
  • Maintain regulatory compliance for manufactured products, including registrations, listings, amendments, submissions, letters to file, labelling, UDI, and other requirements.
  • Create and maintain regular lines of communication across the business to promote quality awareness, regulatory partnership, and harmonization of quality processes.
  • Conduct internal audits and provide guidance regarding best practices and continuous improvement.
  • Promote audit readiness, prepare quality teams for audits by external bodies, including MHRA, BSI, and facilitate audits as needed.
  • Support monitoring, measurement, and effectiveness of the quality systems to continuously improve performance.
  • Partner with teams on the execution of corrective action plans, tracking and verifying that deficiencies are corrected.
  • Maintain current knowledge of MHRA, legislation, best practices, and guidelines related to QA/RA and any changes to applicable laws and regulations
  • Provide consultative guidance to product leadership, quality and other stakeholders of QA/RA issues.
  • Supporting the operations department with QC and H&S support

 

Key Requirements:

  • Experience in Quality Control management
  • Awareness and experience of ISO 13485 Quality System Requirements, Medical Device Directive, ISO 14971 Risk Management for Medical Devices and BS 7177 requirements
  • Understand and comply with all quality procedures
  • Strong communication skills, both verbal and written

My client is looking to start someone ASAP so if you want to be considered for the position then please apply now!

To apply for the Quality Assurance Compliance Specialist role, please send your CV along with your salary details by email to Katie Seed:  kseed@ros.jobs  RoS International Ltd, 16 Parliament Street, Hull, HU1 2AP Tel 01482 211155

RoS International Ltd is a well established and respected Engineering and Technical Recruitment Company.  Since 1991 we have been placing staff into both permanent and contract vacancies throughout the UK.

We often have such a large response to our advertisements that we are unable to provide feedback to every applicant. If you do not receive an email from us within the next 14 days your application has been unsuccessful. We would like to keep your details on file for future vacancies unless you state otherwise.