Quality Assurance Director, Manchester, Medical Devices

Job Reference: #14492 Add to saved jobs

  • Location Manchester
  • Permanent
  • Sector Medical Devices

Job Summary

I’m currently working with a large IVD organisation that has grown considerably and is now looking for a Quality Manager to join their team in the North West of England. The successful applicant will be replacing a consultant and really becoming the voice of Quality throughout the business. The company themselves are a leading global provider within their market. QA Director, Manchester, IVDs, Medical Devices Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Job Overview

• Manage the ISO 13485 accredited Quality Management System
• Continue to drive the implementation and improvement of the Quality Manual and associated procedures
• Lead the 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

Skills Required

• Working to compliance with Medical Devices Directive (93/42/EEC) and US FDA 21 CFR 820
• Significant experience working within an ISO 13485 quality system for the design and development of medical devices and combination products
• Experience with Drug Delivery Devices would be an advantage.

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

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