Quality Specialist

The role will be responsible for supporting the Quality Management Systems within the business ensuring compliance to ISO 13485, ISO 9001, ISO 14001. Working alongside the Regulatory function and closely with Senior Management to develop and deliver a range of proactive and responsive processes to maintain compliance

  • To review, maintain and develop the company QMS system to ensure compliance with relevant standards (ISO 9001, ISO 14001 and working with the Regulatory function on ISO13485) and applicable regulations.
  • To implement the Company’s Quality and Environmental Policy as documented in the Quality and Procedures Manual.
  • To work closely with, and provide support for, the Regulatory function
  • Drive QMS improvement in usability, visibility and engagement
  • Work with the Quality & Regulatory Affairs Administrators and relevant departments to monitor and improve the complaints processes related to service, distribution and dispensing of product
  • Assist the business in developing SOPs to maintain compliance. Review existing SOPs and approve as necessary, offering input to streamline processes where possible
  • Ensure Good Distribution Practice is followed in relation to relevant processes. Work with the Responsible Person to monitor and ensure compliance.
  • Provide training on quality aspects and standards to all levels of the business as required
  • Assist colleagues in using risk management and control procedures
  • To lead on change control within the QARA Department
  • To participate in continuous improvement, corrective actions and business risk minimisation.
  • Develop the internal audit plan to ensure compliance and chair internal audit meetings as required
  • Plan and conduct internal audits and follow up in accordance with the QMS.
  • Undertake external audits on suppliers as required
  • Host audits as required by external regulatory bodies/customers.
  • Promote a proactive quality culture throughout the organisation.
  • Promote quality activities to achieve the standards of excellence as set out in the company’s quality and environmental policies.
  • Represent CliniMed at industry body meetings as required
  • Be prepared to undertake any internal / external training as required.
  • Other duties as requested by Senior Management
  • Behave in a professional manner at all times.
  • Build professional relationships with internal stakeholders that will enhance and grow the QARA function within the business.

Essential:

  • Educated to degree level in a scientific, engineering or relevant discipline
  • Proven quality experience from medical devices or pharmaceutical/ healthcare/cosmetics fields
  • Expert knowledge of ISO9001, ISO 13485
  • Experience of internal auditing
  • Experience interpreting, implementing and communicating changes in Regulatory policy and Quality standards
  • Excellent written communication and presentation skills
  • Ability to engage and influence internal and external customers and champion a positive quality culture across the business
  • Ability to prioritise, plan and organise workload and work to deadlines
  • Highly IT literate
  • Highly numerate with an excellent level of attention to detail.

Desirable:

  • Experience in developing quality strategy
  • Experience of external auditing
  • Experience with ISO14001
  • Knowledge/awareness of ISO 14971

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