Quality Manager

Job Ref: J33012
Sector: Engineering
Sub-sectors: Pharmaceuticals, Medical Devices
Job Type: Permanent
Date Added: 05 August 2019
  • Northwood, London, England, UK Norgine House, Widewater Place Moorhall Road, Harefield, Uxbridge UB9 6NS Northwood London UK UB9 6NS
  • £45,000 - £60,000 per Annum
    ANNUM
  • Molly Cooley
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Are you a medical device quality professional with line management experience? A well-known pharmaceutical company are looking to add a Medical Device Quality Manager to their site in North-West London.

Your role will be to build and maintain a QMS compliant with ISO 13485.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

  • Provide oversight of current and evolving Medical Device regulatory requirements to ensure the MDQMS remains current
  • Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to medical device standards, practices and regulations
  • Act as a leader of global quality and to ensure that their actions and behaviours reflect the norm of the department at all times.
  • Report to senior management through management review on the performance of the Medical Device quality management system and any need for improvement using KPIs
  • Maintain awareness of customer requirements throughout the organization and ensure these are supported by the MDQMS.
  • Design, development and continuous review of the MDQMS to ensure its continues to meet business and regulatory expectations
  • Performs and executes audits in compliance with ISO 13485, Medical Device Directive/Regulation as applicable.
  • Ensure delivery of global medical device audit program to support the company as a distributor and legal manufacturer
ABOUT YOU
  • Excellent Knowledge and proven application of the medical device requirements
  • Strong analytical skills with respect to organisational patterns, to professional and personal interactions between staff and to documented evidence.
  • Experience of setting up and managing MDQMS
  • Medical Device auditing experience

Apply today!

SRG
04/09/2019 16:31:35
GBP 45000 45000