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Quality Manager - East Anglia

Competitive - Medical/Pharmaceutical - Quality
Ref: 62 Date Posted: Tuesday 22 Aug 2017
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Our client is an industry leading supplier for delivery of injectable drug products and point-of-care diagnostic consumables, who are looking to recruit Quality Manager to join their team. As a Quality Manager you will work in the Innovation Department alongside the New Product Development teams. Your key responsibility will be to manage and continue to improve our clients Quality Management System for the design and development of medical devices, parenteral products and combination products.

It is a dynamic, vibrant and fast pace working environment where team work is valued and focused on delivering projects. This company will give you an opportunity to work across a variety of projects. On top of that they offer pension scheme, flexible working hours, private health care, company share options, 28 days holiday and more.

Key skills will be: Key skills will be: expert on ISO 13485 Quality Management Systems for the design and development of medical devices, parenteral and combination products

Your Responsibilities:

  • manage the ISO 13485 accredited Quality Management System
  • Continue to drive the implementation and improvement of the Quality Manual and associated procedures
  • Lead company’s regulatory strategy and dossier compilation & management for parenteral products/combinations.
  • Lead the internal auditing process
  • Champion the proactive management of key Innovation suppliers from a quality perspective; ensuring the needs of projects and QMS are maintained and continuously improved.
  • Assume responsibility for the day to day management and maintenance of the QMS
  • Host quality audits from both our regulatory body and customers
  • Carry out training on quality procedures/processes for the Innovation team and develop Quality training material for new starters
  • Support and guide the Risk Management process and Validation Master Plan for projects
  • Lead the introduction of quality considerations for low volume manufacturing; implementing the procedures that exist and driving improvements as necessary.

Your Qualifications:

  • Educated to degree level (or equivalent), BEng or BSc
  • Significant experience working within an ISO 13485 quality system for the design and development of medical devices, parenteral and combination products
  • Working to compliance with Medical Devices Directive (93/42/EEC, as amended 2007/47/EEC) and US FDA  21 CFR 820, 803, 806
  • Management of an ISO 13485 quality system
  • Evidence of excellent communication skills and of building good relationships with key stakeholders.
  • Experience of compiling and submitting documentation associated with the approval of a medical device from an appropriate regulatory body, such as Technical Files (TF), Design Master Files (DMF), Medical Device Master File (MAF) and 510(k) submissions
  • A 'can do' attitude and plenty of initiative.

Please contact Anna if you require more information email: anna@medicalengineers.co.uk DDL 0161 2600 200

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