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Quality Manager - ISO 13485

Surrey   •  £50000 - £55000 per annum  •  Permanent, Full time


A growing medical device company has an exciting opportunity for a Quality Manager to join its team. This is a varied role supporting a small business with key projects and responsibilities including auditing, preparing for BSI inspections and managing commercial agreements with clients. They are fully compliant with to MDR and seeking an experienced quality professional with experience working to ISO 13485.

Key Duties & Responsibilities:

  • Commitment to continuous Quality Improvement
  • To be fully compliant with FMD's SOPs and MD SOPs relevant to role
  • Ensure procedures and systems are maintained or established to maintain the Company's compliance with ISO 13485 and to enable the manufacture of medical devices in accordance with current national and international legislation; relevant regulations, standards and guidelines
  • To undertake the formal Management Representative role and have day to day responsibility for running the MD QMS
  • Where required, to act as designee to the Regulatory Affairs Director when acting as the Person Responsible for Regulatory Compliance (PRRC)
  • Ensure procedures and systems are maintained or established to maintain the Company's compliance with ICH Good Clinical Practice; current national and international legislation; and relevant regulations, standards and guidelines
  • Ongoing contribution to the maintenance and development of Business Operating Procedures
  • Responsible for maintenance of training and familiarisation matrices, ensuring distribution and documentation of receipt of procedures amongst staff within the Company and the virtual team as appropriate and participation in (and directing of) appropriate training programs
  • Liaise as necessary with third party organisations and relevant Health Authorities to represent the Company interest and resolve Quality related issues
  • Responsible for evaluating and reviewing third party organisation's Quality Incident Reports and for preparing FMD Reports as necessary
  • Responsible for preparing investigation reports for submission to relevant authorities
  • Involved in the management of inspections by regulatory bodies in support of the company's accreditations, as well as those performed by customers and independent associates
  • Responsible for drawing up Internal and External Audit Plans (including the design of audit / inspection programs as necessary)
  • Oversight of the Third Party/Supplier Assessments and Reassessments
  • Responsible for arranging a review of Change Control data as part of the Management Review Process and communicating the status of Change Controls to the R&D Team
  • Responsible for arranging a review of CAPA data as part of the Management Review Process and communicating the status of CAPAs to the R&D Team
  • Jointly responsible for commercial product final release
  • Responsible for handling customer complaints, including the assessment of complaint and vigilance reportability alongside the Head of Quality, and coordinating notifications to Regulatory Bodies when acting as nominated deputy to the Regulatory Affairs Director or Head of Quality
  • Responsible for collating feedback data from production and post-production activities, including implementing the MD Post Market Surveillance Plan, and organising its retrospective review by the Management Review process
  • Responsible for maintaining non-conformance records received from applicable manufacturers
  • Responsible for maintaining all product field safety corrective action records as an input to the Management Review process
  • To provide training and guidance to all staff within the Company as appropriate
  • Undertake inspections of Third Parties/Suppliers
  • Providing assistance on day to day basis to the Research & Development team on quality matters
  • Maintaining a good understanding and awareness of key programmes in all company functions so as to be able to contribute to the development of overall corporate strategy and proper coordination

Knowledge, Competencies and Experience Required:

  • Degree educated
  • Significant years' professional experience in Quality Management Systems relating to medical devices
  • Good knowledge and experience of managing Quality Management Systems, e.g. ISO 13485, GCP, GMP, GDP and Regulation (EU) 2017/745 on Medical Devices (MDR)
  • Significant professional experience in quality management relating to pharmaceuticals
  • Successful experience of being inspected by MHRA/Notified bodies
  • Excellent written and verbal communication skills
  • Good project management skills and capability to work with a small team of people
  • Strong attention to detail
  • Good team member, but also able to work on own initiative and self-sufficient within a small company structure
  • Ability to establish priorities and meet deadlines
  • Strong work ethic, enthusiastic and motivated
  • Approachable with the ability to mentor staff
  • Excellent computer skills, including strong working knowledge of Microsoft Office (Word, Excel, Power Point and Outlook)


You must have the right to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 7095
  • Posted: 12th October 2021
  • Expires: 9th November 2021

Cranleigh Scientific

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